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EUSA Pharma announces FDA approval for Siltuximab for COVID-19 associated acute respiratory distress syndrome

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EUSA Pharma announces FDA approval for Siltuximab for COVID-19 associated acute respiratory distress syndrome
JULY 02, 2020: “EUSA Pharma, a global biopharmaceutical company focused on oncology and rare disease announced that the U.S. FDA has approved a randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS).

Siltuximab is a monoclonal antibody that directly neutralizes interleukin (IL)-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions, including COVID-19.

It specifically binds to IL-6, thereby inactivating IL-6 induced signalling.

Lee Morley, Chief Executive Officer, EUSA Pharma, said: “Since the start of the pandemic, a growing body of evidence has been published highlighting that COVID-19 associated ARDS may exhibit features of systemic hyperinflammation, resulting from excessive cytokine production – the so-called ‘cytokine storm’ – with IL-6 recognized as a key driver of this severe condition.

Treatment approaches neutralizing  IL-6 could therefore play a key role in mitigating further detrimental inflammation and progression to respiratory failure, which can be fatal.
Coronavirus treatment: List of Vaccines and drugs in the pipeline for COVID-19

Coronavirus treatment: Vaccines and drugs in the pipeline for COVID-19

We thank the FDA for recognizing the importance of this clinical trial and the quick approval we received. Our plan now is to initiate the study as quickly as possible with the hope of seeing improved clinical outcomes in these critically ill patients.”

To date, several independent clinical trials have begun globally to explore the safety and efficacy of siltuximab for the treatment of severe COVID-19 patients.

Final results from the Papa Giovanni XXIII Hospital sponsored SISCO (Siltuximab In Serious COVID-19) Study, an observational cohort control trial investigating siltuximab plus standard of care in COVID-19 patients with serious respiratory complications, are available via pre-print summary.

 However, the newly approved confirmatory clinical trial is vital because these findings require validation in a well-controlled randomized study and there is limited published data on the safety and efficacy of siltuximab in COVID-19.

Siltuximab is also not yet FDA-approved for complications associated with COVID-19. 

The New Clinical Trial

EUSA Pharma has received FDA approval to proceed with a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated ARDS, compared to placebo plus standard of care.

The multicentre trial will aim to enrol approximately 400 patients with viral ARDS and elevated serum levels of IL-6.

The primary objective is to evaluate all-cause mortality at 28 days with the addition of siltuximab to standard of care, compared to placebo plus standard of care. Secondary objectives include: time to 7-category ordinal scale of clinical status improvement, ventilator-free days within 28 days, organ failure-free days, intensive care unit length of stay, hospital length of stay, lung function and radiographic improvement.

SYLVANT® (siltuximab)

SYLVANT is an IL-6 targeted monoclonal antibody approved by the FDA and the European Medicines Agency (EMA) as well as regulatory bodies in a number of other jurisdictions worldwide, for the treatment of patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative (also known as idiopathic MCD).

EUSA Pharma has exclusive rights to SYLVANT globally. EUSA Pharma has granted BeiGene, Ltd., exclusive development and commercialization rights to SYLVANT in Greater China.

SYLVANT is not licensed for the treatment of COVID-19.

Indications and Usage of SYLVANT – See Full Prescribing Information for Additional Details.

SYLVANT is indicated for the treatment of patients with MCD who are HIV negative and HHV-8 negative.

Limitations of Use: SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study.

Contraindications: Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.

Dosage and Administration

Administer SYLVANT 11 mg/kg over 1 hour as an intravenous infusion every 3 weeks until failure.

Perform hematology laboratory tests prior to each dose of SYLVANT therapy for the first 12 months and every 3 dosing cycles thereafter.

If treatment criteria outlined in the Prescribing Information are not met, consider delaying treatment with SYLVANT. Do not reduce dose.

Do not administer SYLVANT to patients with severe infections until the infection resolves.

Discontinue SYLVANT in patients with severe infusion related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndromes. Do not reinstitute treatment.”
https://www.eusapharma.com/news/eusa-pharma-announces-fda-approval-of-phase-3-clinical-trial-for-siltuximab-in-hospitalized-patients-with-covid-19-associated-acute-respiratory-distress-syndrome/

ViiV Healthcare to present new data on long-acting regimens for HIV prevention and treatment

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ViiV Healthcare to present new data on long-acting regimens for HIV prevention and treatment
“ViiV Healthcare to present new data on long-acting regimens for HIV prevention and treatment, alongside extensive insights into the evolving needs of people living with HIV at 23rd International AIDS Conference (AIDS 2020: Virtual)

02 Jul 2020: ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, and its clinical trial partners, will be presenting over 20 abstracts during next week at the 23rd International AIDS Conference (AIDS 2020: Virtual), being held 6-10 July.

Because of the COVID-19 pandemic, the conference will, for the first time, be completely virtual.

Highlights from ViiV Healthcare and study partners at AIDS 2020 will include the final efficacy analysis from the global HIV Prevention Treatment Network (HPTN ) 083 study evaluating investigational long-acting cabotegravir for HIV prevention; 48-week data from CUSTOMIZE, an implementation research study on how to implement, if approved, a new, once-monthly injectable HIV treatment in US healthcare practices; and results from the Positive Perspectives Wave 2 study, providing extensive insights from more than 2,300 people living with HIV (PLHIV) in 25 countries.

ViiV Healthcare’s commitment towards ending paediatric AIDS by 2025 will be showcased with a media panel to introduce the new Positive Action Breakthrough grants alongside our global partners selected to receive ViiV Healthcare funding, and a satellite symposium on delivering an Integrated Approach for Adolescent Mothers and their Children. 

Kimberly Smith, Head of Research & Development, ViiV Healthcare, said: “The data we’re presenting at AIDS 2020 show the continued depth and focus of ViiV Healthcare’s patient-centred approach to innovation and the strength of our commitment to the community. 

We’ll be sharing the significant advances we’ve made not just for the treatment of HIV, but for prevention as well, in some of the populations most disproportionately impacted by HIV.

We’ll also share the in-depth insights gained from more than 2,300 people living with HIV that will help address their treatment needs and challenges.”

Key abstracts to be presented by ViiV Healthcare and study partners at AIDS 2020

Final efficacy analysis from the global HPTN 083 study evaluating cabotegravir for HIV prevention: The HPTN 083 study, with approximately 4,600 participants across 40 sites in North and South America, Asia and Africa, is one of the first-ever clinical trials to directly compare two active HIV prevention agents.

In a planned interim review, the independent Data and Safety Monitoring Board recommended the blinded, randomised portion of the study be stopped early and results released.

Detailed final efficacy results from this interim review will be presented at AIDS 2020.

Related News: U.S FDA issues complete response letter to ViiV Healthcare for the use of investigational cabotegravir and rilpivirine long-acting regimen for the treatment of HIV

ViiV HIV prevention trial stopped early on the efficacy

48-week findings from the implementation research study, CUSTOMIZE (Cabotegravir plus Rilpivirine in the US To Optimize and Measure Implementation and Experience): Data to be presented at AIDS 2020 will outline the quantitative findings from ViiV Healthcare’s implementation research study, CUSTOMIZE.

ViiV Healthcare worked with 24 healthcare providers and clinic administrators from eight sites to identify and evaluate approaches to implementing the investigational once-monthly, long-acting, investigational regimen of cabotegravir and rilpivirine for the treatment of HIV, into clinical practice.

Long-acting treatments have the potential to change HIV management by replacing daily pills with long-acting dosing regimens, and results from the CUSTOMIZE trial will help to find solutions to real-world challenges in implementing such treatments.

Global Positive Perspectives Wave 2 study results: ViiV Healthcare will showcase results from the second wave of Positive Perspectives research at AIDS 2020.

The study captured insights from more than 2,300 people living with HIV from 25 countries and the results highlight the importance of a holistic approach involving people living with HIV in open dialogue and joint decision-making with their healthcare providers.

The external Positive Perspectives advisory committee also developed a manifesto, in partnership with ViiV Healthcare, containing specific recommendations for policymakers to include quality of life in assessments and encourage open and active dialogue, which will be outlined at the conference.

Advancing HIV treatment and care in paediatrics: Leading the way with the delivery of innovative science-led, access-driven solutions to ensure children living with HIV are not left behind, ViiV Healthcare has made a commitment towards ending paediatric AIDS by 2025.

Among the events at AIDS 2020, ViiV Healthcare will host two sessions focusing on paediatric treatment and care:

  • Paediatric Media Panel (3 July 2020, 13:30-14:30 BST): Hosted ahead of the AIDS 2020 Conference, this session will be open to registered journalists only and will introduce ViiV Healthcare’s new Positive Action Breakthrough grant supporting the work of the Elizabeth Glaser Pediatric AIDS Foundation, the United Nations Children’s Fund, Aidsfonds and Paediatric AIDS Treatment for Africa, which will focus on seven priority countries.

    The session will also touch on the upcoming Positive Action Momentum grants for teenage mothers, which will support progress towards prevention and ultimately elimination of mother to child transmission of HIV; and showcase ViiV Healthcare’s leading role in accelerating development and access to age-appropriate formulations of the latest medicines.
  • Delivering an Integrated Approach for Adolescent Mothers and their Children (8 July 2020, 07:00-08:00 BST): ViiV Healthcare Positive Action, together with the Coalition for Children Affected by AIDS (the Coalition), will be co-hosting a satellite symposium on HIV-affected adolescent mothers and their children at AIDS 2020.

    The satellite will enable the President’s Emergency Plan for AIDS Relief and the Global Fund to reflect together upon a draft advocacy agenda for HIV-affected adolescent mothers and their children, developed by 43 experts at a learning session the Coalition co-hosted with the World Health Organisation in December 2019.”
    https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-to-present-new-data-on-long-acting-regimens-for-hiv-prevention-and-treatment-at-aids-2020-virtual/

Johnson & Johnson Announces EC Approval for Janssen’s Preventive Ebola Vaccine

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Johnson & Johnson Announces EC Approval for Janssen’s Preventive Ebola Vaccine
1 July 2020: “The European Commission has approved Johnson & Johnson group Janssen’s Ebola vaccine regimen for the prevention of Ebola Virus Disease caused by the Zaire ebolavirus species in individuals aged one year and above.

Two marketing applications were submitted to the European Medicines Agency (EMA) for the vaccines composing the two-dose regimen, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo).

Ad26.ZEBOV, the first dose, is based on Janssen’s AdVac viral vector technology, and MVA-BN-Filo, the second dose, is based on Bavarian Nordic’s MVA-BN technology, administered approximately eight weeks later.

Marketing authorisation under exceptional circumstances was granted following accelerated assessment of the applications and a positive opinion by the agency’s human medicines committee.

Related News: WHO Director-General’s Statement on IHR Emergency Committee on Ebola Virus Disease in the Democratic Republic of the Congo

https://lifepronow.com/blog/2020/04/12/new-ebola-case-confirmed-in-the-democratic-republic-of-the-congo/

The vaccine regimen is specifically designed to induce long-term immunity against the Ebola virus in adults and children aged one year and above. It will be used to support preventive vaccination in countries most at risk of outbreaks, as well as for other at-risk groups such as healthcare workers, biosafety level 4 (BSL4) laboratory workers, military personnel deployed in the affected regions, airport staff and visitors to high-risk countries.

Janssen is now collaborating with the World Health Organisation (WHO) on vaccine pre-qualification, “which should help accelerate registration of its preventive Ebola vaccine regimen in African countries and facilitate broader access to those most in need,” J&J noted.

Janssen is now collaborating with the World Health Organisation (WHO) on vaccine pre-qualification, “which should help accelerate registration of its preventive Ebola vaccine regimen in African countries and facilitate broader access to those most in need,” J&J noted.”

https://johnsonandjohnson.gcs-web.com/static-files/1c979f4f-cad3-4f8b-9a22-69aaac503570

Pfizer and biontech announce early positive data of mRNA-based vaccine candidate against SARS-COV-2

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Pfizer and biontech announce early positive data of mRNA-based vaccine candidate against SARS-COV-2

 July 01, 2020: “Pfizer and BioNTech SE announced preliminary data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2, the virus causing the current global pandemic.

The BNT162 program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target antigen.

The manuscript describing the preliminary clinical data for the nucleoside-modified messenger RNA (modRNA) candidate, BNT162b1, which encodes an optimized SARS-CoV-2 receptor binding domain (RBD) antigen, is available on an online preprint server at https://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1 and is concurrently undergoing scientific peer-review for potential publication.

Overall, the preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing antibody titers.

“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer.

“We are dedicated to develop potentially groundbreaking vaccines and medicines, and in the face of this global health crisis, we approach this goal with the utmost urgency.

We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible.”

“These preliminary data are encouraging in that they provide an initial signal that BNT162b1 targeting the RBD SARS-CoV-2 is able to produce neutralizing antibody responses in humans at or above the levels observed in convalescent sera – and that it does so at relatively low dose levels.

We look forward to providing further data updates on BNT162b1,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

The ongoing U.S. Phase 1/2 randomized, placebo-controlled, observer-blinded study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1.

The initial part of the study included 45 healthy adults 18 to 55 years of age.

Preliminary data for BNT162b1 was evaluated for 24 subjects who received two injections of 10 µg and 30 µg, 12 subjects who received a single injection of 100 µg, and 9 subjects who received 2 doses of placebo control.

The participants received two doses, 21 days apart, of placebo, 10 µg or 30 µg of BNT162b1, or received a single dose of 100 µg of the vaccine candidate.

Because of a strong vaccine booster effect, the highest neutralizing titers were observed seven days after the second dose of 10 µg or 30 µg on day 28 after vaccination.

The neutralizing GMTs were 168 and 267 for the 10 µg and 30 µg dose levels, respectively, corresponding to 1.8- and 2.8-times the neutralizing GMT of 94 observed in a panel of 38 sera from subjects who had contracted SARS-CoV-2.

In all 24 subjects who received 2 vaccinations at 10 µg and 30 µg dose levels of BNT162b1, elevation of RBD-binding IgG concentrations was observed after the second injection with respective GMCs of 4,813 and 27,872 units/ml at day 28, seven days after immunization.

These concentrations are 8- and 46.3-times the GMC of 602 units/ml in a panel of 38 sera from subjects who had contracted SARS-CoV-2.

At day 21 after a single injection, the 12 subjects who received 100 µg of BNT162b1 had an RBD-binding IgG GMC of 1,778 units/ml and a SARS-CoV neutralizing GMT of 33, which are 3-times and 0.35-times, respectively, the GMC and GMT of the convalescent serum panel.

At the 10 µg or 30 µg dose levels, adverse reactions, including low grade fever, were more common after the second dose than the first dose. Following dose 2, 8.3% of participants who received 10 µg and 75.0% of participants who received 30 µg BNT162b1 reported fever ≥ 38.0 °C.

Local reactions and systemic events after injection with 10 µg and 30 µg of BNT162b1 were dose-dependent, generally mild to moderate, and transient.

The most commonly reported local reaction was injection site pain, which was mild to moderate, except in one of 12 subjects who received a 100 µg dose, which was severe.

No serious adverse events were reported. Given higher numbers of subjects experiencing local reactions and systemic events after a single 100 µg dose with no significant increases in immunogenicity compared to the 30 µg dose level, the 12 participants in the 100 µg group were not administered a second dose.

These preliminary data, together with additional preclinical and clinical data being generated, will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress to a large, global Phase 2b/3 safety and efficacy trial.

That trial may involve up to 30,000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval to proceed is received.

The preliminary clinical data from this ongoing study have been submitted for potential publication in a peer-reviewed journal and is available on an online preprint manuscript server.

The BNT162b1 candidate remains under clinical study and is not currently approved for distribution anywhere in the world.

If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.

In that event, BioNTech and Pfizer would work jointly to distribute the potential COVID-19 vaccine worldwide (excluding China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for both clinical development and commercialization).

The development of the vaccine is also supported by partners like Acuitas Therapeutics. The Canadian company provides lipid nanoparticles (LNP) for the formulation of various mRNA vaccines.”
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-early-positive-data-ongoing-0

Sandoz reviewing options after Federal Circuit upholds lower court ruling in biosimilar Erelzi® case

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Sandoz reviewing options after Federal Circuit upholds lower court ruling in biosimilar Erelzi® case

Jul 01, 2020: “Sandoz, a Novartis division and a global leader in biosimilars, announced that the US Court of Appeals for the Federal District has ruled against Sandoz in patent litigation concerning the Sandoz biosimilar Erelzi® (etanercept-szzs) for reference medicine Enbrel®* (etanercept).

This decision upholds a prior ruling from the New Jersey District Court, which declared the Amgen patents valid. Sandoz is evaluating its options, which may include an appeal to the US Supreme Court. 

“Sandoz will continue its efforts to make Erelzi available to US patients with autoimmune and inflammatory diseases,” said Carol Lynch, President of Sandoz US and Head of North America.

“Our company respects valid intellectual property, however Sandoz continues to believe the patents asserted by Amgen are not valid, and that it should not be able to use them to extend the drug’s exclusivity.”

Sandoz is the first company to receive approval from the US Food and Drug Administration (FDA) for a biosimilar etanercept.

Erelzi has been approved in the US for more than three years, since August 2016, however, Sandoz has been unable to launch this medicine in the US due to the ongoing patent litigation with Amgen.

With the trend towards increased spending on specialty medicines only expected to grow, biosimilars play an important role in enabling more patients to access biologic medicines and may offer significant savings for patients, helping to alleviate the overburdened healthcare system.

Estimates suggest that biosimilar etanercept could save the US healthcare system around USD one billion a year.

“Biosimilars can make tremendous contributions to the sustainability of US healthcare and enhance patient access to biologic medicines, which are often life-changing treatment options for patients with chronic illness,” said Colin C. Edgerton, MD, a rheumatologist and Executive Chairman of the American Rheumatology Network.

“Data and real-world experience affirm there are no changes in safety and efficacy when patients switch between a biosimilar and a reference medicine.”

Sandoz will continue to help millions of patients in oncology, immunology, endocrinology and other underserved therapy areas access biologic medicines sustainably and affordably.

Sandoz was the first to launch a biosimilar in the US, and Erelzi is one of the company’s four FDA-approved biosimilar medicines.

Biosimilars

Biosimilars are approved biologics with comparable quality, safety and efficacy to existing biologics, and go through an extensive regulatory evaluation and approval process.

A 10-year-plus growing body of real-world evidence in highly-regulated markets shows biosimilar adoption greatly increases usage of biologic medicines while delivering matched safety, efficacy and quality profiles.

Erelzi®
Erelzi is the Sandoz biosimilar of the reference medicine Enbrel®. Erelzi has been studied in a global development program, which included a comprehensive comparison of Erelzi and Enbrel® at the analytical, preclinical, and clinical levels.

The program included preclinical studies, pharmacokinetic (PK) studies, and the Phase III confirmatory safety and efficacy EGALITY study.

Erelzi is approved by the FDA for the following indications: adult rheumatoid arthritis (RA), ankylosing spondylitis (AS), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA) and moderate to severe plaque psoriasis (PsO). “F

https://www.novartis.com/news/media-releases/sandoz-reviewing-options-after-federal-circuit-upholds-lower-court-ruling-biosimilar-erelzi-case

Coronavirus (COVID-19) Update: Daily Roundup July 1, 2020

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Coronavirus (COVID-19) Update: Daily Roundup July 1, 2020

July 01, 2020: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • Today, the U.S. Food and Drug Administration (FDA) further supported its effort to evaluate diagnostic tests for COVID-19 by distributing the first round of SARS-CoV-2 reference panel materials.

    The panel is an independent performance validation step — for diagnostic tests of SARS-CoV-2 infection — being used for clinical, not research, purposes.

    The reference panel can help characterize a test’s level of detection and establish relative sensitivity among tests.

    The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process or whose tests have been issued a EUA.

    The FDA will provide the reference panel to developers at the appropriate stage in the process.

    Related News: https://lifepronow.com/blog/2020/07/01/coronavirus-covid-19-update-daily-roundup-june-30-2020/
  • On June 30, FDA issued Emergency Use Authorizations to:
    • TNS Co., Ltd (Bio TNS), for its COVID-19 RT-PCR Peptide Nucleic Acid (PNA), which is authorized for use for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens.

      Emergency use of this molecular test is limited to laboratories certified under CLIA that meet the requirements to perform high-complexity tests.
    • The Kroger Co., for its Kroger Health COVID-19 Test Home Collection Kit, which can be used by individuals to self-collect nasal swab specimens at home, video-observed by a health care provider, when determined by a healthcare provider to be appropriate. Testing is limited to laboratories that:
    • (1) Are certified under the Clinical Laboratory Improvement Amendments of 1988 and meet requirements to perform high-complexity tests, and

      (2) run the specimens on an in vitro diagnostic molecular test that is specifically indicated for use with this kit.
    • Psomagen, Inc., for its Psoma COVID-19 RT Test, which is authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory swab specimens (e.g., nasal, mid-turbinate, nasopharyngeal, oropharyngeal) and bronchoalveolar lavage specimens from individuals whose healthcare provider suspects they may have contracted COVID-19.

      Testing is limited to Psomagen, Inc., which is certified under the Clinical Laboratory Improvement Amendments of 1988, and meets requirements to perform high-complexity tests.
  • On June 30, the FDA and the FTC jointly issued a warning letter to the Center for Wellness and Integrative Medicine for selling unapproved and unauthorized products to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.

    The seller offers a “COVID Supplement Protection Pack” (also referred to as the “COVID Household Value Pack”), Thymosin-Alpha, and Methylene Blue Capsules for sale in the United States.

    There are currently no FDA-approved products to prevent or treat COVID-19.

    The warning letter advised the company to take immediate corrective actions to cease the sale of the unapproved and unauthorized products.

    Consumers concerned about COVID-19 should consult with their health care provider.
  • Testing updates:
    • To date, the FDA has currently authorized 161 tests under EUAs; these include 135 molecular tests, 25 antibody tests, and 1 antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-july-1-2020

FDA Approves BAVENCIO for Locally Advanced or Metastatic Urothelial Carcinoma

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FDA Approves BAVENCIO for Locally Advanced or Metastatic Urothelial Carcinoma
June 30, 2020: “Merck and Pfizer announced that the US FDA has approved the supplemental Biologics License Application (sBLA) for BAVENCIO® (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

The approval is based on results from the Phase III JAVELIN Bladder 100 study, which demonstrated a significant 7.1-month improvement in median overall survival (OS) with BAVENCIO as first-line maintenance plus best supportive care (BSC) compared with BSC alone: 21.4 months (95% CI: 18.9 to 26.1) vs. 14.3 months (95% CI: 12.9 to 17.9).

This statistically significant improvement in OS represents a 31% reduction in the risk of death in the overall population (HR 0.69; 95% CI: 0.56 to 0.86; 2-sided P=0.001).

OS was measured from the time of randomization, after patients were treated with four to six cycles of gemcitabine plus cisplatin or carboplatin over a period of approximately four months.

The JAVELIN Bladder 100 results were presented at the ASCO 2020 Virtual Scientific Meeting.

Related News: EUROPEAN MEDICINES AGENCY VALIDATES APPLICATION FOR BAVENCIO® for UROTHELIAL CARCINOMA

BAVENCIO (avelumab) extensively Improved Overall Survival in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

“As the first immunotherapy to demonstrate a statistically significant improvement in overall survival in the first-line setting in locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab is one of the most significant advances in the treatment paradigm in this setting in 30 years,” said Petros Grivas, M.D., Ph.D., one of the principal investigators in the JAVELIN Bladder 100 trial.

“With median overall survival of more than 21 months, measured from randomization, the longest overall survival in a Phase III trial in advanced urothelial carcinoma, the JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease.”

Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease based on high initial response rates.

However, most patients will ultimately experience disease progression within nine months of initiation of treatment, and only 5% of patients with metastatic disease at diagnosis will live longer than five years.

“Many patients newly diagnosed with advanced urothelial carcinoma receive benefit from initial chemotherapy, but we still need treatment options that can help patients live longer,” said Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network. 

“We wholeheartedly support the development of new and promising treatments like BAVENCIO that can offer patients and their loved ones hope.”

For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.

The FDA previously approved BAVENCIO under the accelerated approval program in 2017 for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, based on tumor response rate and duration of response.

Continued approval was contingent upon verification of clinical benefit, which was demonstrated in JAVELIN Bladder 100.

The FDA has now converted the accelerated approval to full approval.

“Today’s approval of BAVENCIO in the most common type of advanced bladder cancer underscores our commitment to advancing scientific innovation and transforming outcomes for people with genitourinary cancers,” said Andy Schmeltz, Global President, Pfizer Oncology.

“With this approval for BAVENCIO, we have the opportunity to fundamentally shift the standard of care in the first-line setting of advanced bladder cancer.

Our focus now is to work closely with the GU community to ensure that this novel and potentially life-changing treatment paradigm is rapidly integrated into clinical practice,” said Rehan Verjee, President of North America and Global Head of Innovative Medicine Franchises for the Biopharma business of Merck.

JAVELIN Bladder 100

JAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus BSC versus BSC alone in patients with locally advanced or metastatic UC that did not progress with first-line platinum-containing chemotherapy as per RECIST v1.1.

A total of 700 patients were randomly assigned to receive either BAVENCIO (10 mg/kg intravenous infusion every 2 weeks) plus BSC (n=350) or BSC alone (n=350).

The primary endpoint was OS in the two primary populations of all randomized patients and patients with PD-L1+ tumors defined by the Ventana SP263 assay.

Secondary endpoints included progression-free survival, anti-tumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers and patient-reported outcomes in the two primary populations.

All primary and secondary endpoints are measured from the time of randomization, after completion of four to six cycles of chemotherapy. Patients with autoimmune disease or a medical condition that required immunosuppression were excluded.

In PD-L1+ patients (n=358, 51%), the risk of death was reduced by 44% in the BAVENCIO arm versus the control arm (HR 0.56; 95% CI: 0.40 to 0.79; 2-sided p-value <0.001).

Consistent results were observed across the pre-specified subgroups of complete or partial response versus stable disease to first-line chemotherapy.

 In an exploratory analysis of patients with PD‑L1‑negative tumors (n=271, 39%), the OS hazard ratio was 0.85 (95% CI: 0.62, 1.18).

A fatal adverse reaction (sepsis) occurred in one (0.3%) patient receiving BAVENCIO plus BSC. Serious adverse reactions occurred in 28% of patients receiving BAVENCIO plus BSC.

Serious adverse reactions in ≥1% of patients included urinary tract infection (including kidney infection, pyelonephritis, and urosepsis) (6.1%), pain (including abdominal, back, bone, flank, extremity, and pelvic pain) (3.2%), acute kidney injury (1.7%), hematuria (1.5%), sepsis (1.2%), and infusion-related reaction (1.2%).

The most common adverse reactions (≥20%) in patients receiving BAVENCIO plus BSC were fatigue, musculoskeletal pain, urinary tract infection, and rash.”

https://www.merckgroup.com/en/news/bavencio-avelumab-fda-approval.html

ViiV Healthcare selects projects for HIV/COVID-19 response fund

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ViiV Healthcare selects projects for HIV/COVID-19 response fund
“ViiV Healthcare announces grantees selected as part of £3 million Fund dedicated to HIV research and community-based programmes during COVID-19 pandemic

June 30, 2020: ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders announced that 109 projects from 26 countries will be supported by its Global HIV and COVID-19 Emergency Response Fund.

The Fund, which was launched on 27 April 2020, will provide critical financial resources at a time when COVID-19 threatens to erode more than a decade’s progress in AIDS-related mortality1 and represents ViiV Healthcare’s ongoing commitment to ending the HIV and AIDS epidemic.

During a three-week request for proposal (RFP) period, ViiV Healthcare received more than 400 applications from across the world, with eligible submissions coming from Africa, Asia, Europe, South America and the US. The Fund comprises a Research Emergency Response Fund and a Community Emergency Response Fund.

The Research Fund will support studies into the medical and scientific effects of COVID-19 on people living with HIV, including the impact of co-morbidities.

The Community Fund will focus on community-based organisations, and their work to counteract disruption to HIV care services and support caused by the pandemic. Organisations were asked to apply for funding from one of the two streams.

Stephen Rea, Head of External Affairs and Communications at ViiV Healthcare said: “The overwhelming response from research and community-based organisations to our Global HIV and COVID-19 Emergency Response Fund underlines the significant burden felt by people living with HIV during the pandemic.

Very understandably, people living with HIV and their physicians have mounting questions about the risks COVID-19 poses, and so we have elected to use our Research grants to support those studies seeking to find answers.

It’s our hope that our Community grants will help mitigate some of the disruptions to health services and supplies, which the WHO and UNAIDS have estimated could lead to more than half a million additional AIDS-related deaths.

We see the valuable work afforded by both Funds as critical to ensuring we leave no person living with HIV behind.”

Research Emergency Response Fund Grants
The £1.5 million Research Emergency Response Fund aims to support crucial studies into the medical and scientific impact of COVID-19 on people living with HIV and is being split across seven projects spanning three priority areas of interest: epidemiology and real-world data; healthcare management initiatives in COVID-19 environments; and biomarkers indicative of disease susceptibility, severity and progression. 

Dr. Steven Grinspoon, Professor of Medicine, Harvard Medical School and one of the Lead Investigators of the REPRIEVE study, said: “With support from ViiV Healthcare, we will investigate an innovative approach, using proteomics, to test whether the introduction of statins will mitigate the severity of COVID-19 in people living with HIV, and whether such effects will lead to an improved response to COVID-related inflammation, immune activation, and complications in the heart and lungs.

Through our research, we hope to provide much-needed information about COVID-19, the impact of HIV on the body’s immune response to COVID-19, and the possible protective effects of statins that will be important for people living with HIV as well as the general population.”

Community Emergency Response Fund Grants
This £1.5 million in funding will be shared between 102 community-based projects that strive to address specific challenges facing the HIV community as a direct result of the pandemic.

The projects span four categories: maintaining access to HIV treatment* and care; providing online support in lieu of face-to-face delivery; financial aid to help sustain essential community workers and services; and monitoring mechanisms to track community feedback around the impact of COVID-19. 

Nathaly Rubio-Torio, Executive Director of VOCES Latinas in New York City (NYC) said: “The devastation our community of Western Queens in NYC is facing due to COVID-19 is like no other, and it has intensified the need for basic necessities like food and shelter.

With support from ViiV Healthcare and others who are stepping up in creative ways, we’re providing vulnerable people living with HIV and AIDS and our wider community with the essentials, as we continue to work to connect people to care.”

The broader COVID-19 response
We are proud of everything our majority shareholder, GSK, is doing to contribute to solutions to the COVID-19 pandemic.

This includes the research and production of candidate COVID-19 vaccines and the ground-breaking collaboration recently announced between GSK and Sanofi, bringing together two of the world’s largest vaccine companies to fight COVID-19. “
https://viivhealthcare.com/en-gb/media/press-releases/2020/june/viiv-healthcare-announces-grantees-selected-as-part-of-p3-millio/

CMA imposes £1.2m fines for price-fixing in the private eye care

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CMA imposes £1.2m fines for price-fixing in the private eye care

“Spire Healthcare admits price-fixing for eye care over dinner with opthalmologists and pays £1.2 million fine.

July 01, 2020: Spire Healthcare has admitted one of its private hospitals set up an illegal price-fixing agreement on consultancy fees for people suffering from eye disorders such as cataracts and glaucoma.

It is to pay £1.2 million in fines from the Competition and Markets Authority regulator.

The private hospital giant admitted illegally fixing prices with seven consultant opthalmologists to charge self-pay patients a £200 fee for initial private consultations.

The arrangement was agreed after a dinner organised by the hospital’s management at which the fees were discussed.

After the meal, a Spire employee emailed the consultants to suggest the agreed price. They agreed, resulting in four of them raising their prices from £180. The others were already charging £200.

However, one blew the whistle on the cartel and the Competition and Markets Authority launched an investigation.

The consultants received fines of between £642 and £3859 and escaped being named. The whistleblower was not fined at all.

It is the second recent case of private opthalmologists breaking competition law. A membership organisation of consultants were fined £382,500 previously for cartel behaviour in 2015.

The price fixing arrangement was in place from at least 29 August 2017 to 3 July 2019 and was organised by Spire’s Regency hospital in Macclesfield.

CMA executive director of enforcement Michael Grenfell said: “Initial consultations are an essential first step for people suffering from eye disorders. It is unacceptable that patients were unable to shop around and get the best deal because Spire and the consultants illegally set a minimum consultation fee.”

“It is particularly disappointing that the CMA has had to take action in the private ophthalmology sector again, following a previous finding of anti-competitive practices in the sector in 2015. Today’s decision, and the subsequent fines, send a clear signal that we will not tolerate anti-competitive behaviour.”

Spire said it had not profited from the cartel and that the hospital had “facilitated the alignment [of prices] with an intention to simplify pricing for patients”.

It said it was “disappointed” with its failure to live up to its “strong compliance culture.”
https://www.standard.co.uk/front/spire-opthalmologists-fine-cma-cartel-pricefixing-a4485096.html

Coronavirus (COVID-19) Update: Daily Roundup June 30, 2020

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Coronavirus (COVID-19) Update: Daily Roundup June 30, 2020

June 30, 2020: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • Today, the FDA took action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations related to licensure for those developing COVID-19 vaccines.

    The guidance, titled “Development and Licensure of Vaccines to Prevent COVID-19,” describes the agency’s current recommendations regarding the data needed to facilitate the manufacturing, clinical development, and approval of a COVID-19 vaccine.

    The FDA has the scientific expertise to evaluate any potential COVID-19 vaccine candidate regardless of the technology (e.g., DNA, RNA, protein and viral vector) to produce or administer the vaccine.

    Related news: https://lifepronow.com/blog/2020/06/30/coronavirus-covid-19-update-daily-roundup-june-29-2020/

    The guidance provides an overview of key considerations to satisfy requirements for chemistry, manufacturing and control, nonclinical and clinical data through development and licensure, and post-licensure safety evaluation.

    Given the current understanding of SARS-CoV-2 immunology, the goal of development programs at this time should be to support traditional FDA approval by conducting studies to directly evaluate the ability of the vaccine to protect humans from SARS-CoV-2 infection and/or disease.

    The guidance also notes that, as more is learned about SARS-CoV-2 immunology and vaccine immune responses, consideration may be given to the FDA’s Accelerated Approval pathway for vaccine licensure.

    The guidance also addresses considerations regarding Emergency Use Authorization (EUA) of an investigational vaccine, making clear that an assessment regarding any potential EUA for a COVID-19 vaccine would be made on a case-by-case basis considering the target population, the characteristics of the product, and the totality of the relevant available scientific evidence including preclinical and human clinical study data on the product’s safety and effectiveness.
  • FDA issued an Emergency Use Authorization to LifeHope Labs for its molecular-based LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel.
  • In the second FDA Insight podcast, titled “All About COVID-19 Testing,” host Dr Anand Shah, FDA’s deputy commissioner for Medical and Scientific Affairs, is joined by Toby Lowe, associate director for FDA’s In Vitro Diagnostics Program in the Center for Devices and Radiological Health, discussing “all things” COVID-19 testing.
  • Testing updates:
    • To date, the FDA has authorized 157 tests under EUAs; these include 132 molecular tests, 24 antibody tests, and 1 antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-30-2020

European Commission approves daurismotm™ for acute myeloid leukaemia

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European Commission approves daurismotm™ for acute myeloid leukaemia
 June 29, 2020: “Pfizer announced that the European Commission approved DAURISMOTM™ (glasdegib), a Hedgehog pathway inhibitor, in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly diagnosed (de novo or secondary) acute myeloid leukemia (AML) in adult patients who are not candidates for standard chemotherapy.

The approval follows the medicine’s positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) earlier this year, as well as the medicine’s approval by the U.S. Food and Drug Administration (FDA) in November 2018.

“The standard of care for people with acute myeloid leukemia is intensive chemotherapy, however, this is not an option for many elderly people and those who have certain health conditions prior to receiving their diagnosis,” said Masum Hossain, Regional President, Oncology International Developed Markets at Pfizer.

“Through the European Commission approval of DAURISMO, we are proud to further deliver on our decades long commitment to people living with blood cancers by offering this new treatment option for certain patients in Europe with acute myeloid leukemia, who previously had limited treatment options.”

The European Commission’s approval of DAURISMO is based on results from the Phase 2 BRIGHT 1003 trial, which showed DAURISMO nearly doubled median overall survival compared to LDAC alone (8.3 months vs. 4.3 months, HR 0.463, 95% CI [0.299,0.717]) in patients with previously untreated (de novo or secondary) AML who were not eligible for intensive chemotherapy.

The difference represented a 54 percent reduction in the risk of death for patients treated with DAURISMO plus LDAC (HR: 0.463, 95% CI: 0.299, 0.717, one-sided p-value 0.0002).1

“The BRIGHT 1003 trial demonstrated that DAURISMO in combination with low-dose cytarabine nearly doubled overall survival compared to low-dose cytarabine alone,” said Dr. Pau Montesinos, M.D., Ph.D., attending physician at the University Hospital La Fe in Valencia, Spain.

“People with previously untreated acute myeloid leukemia who cannot withstand intensive chemotherapy are in urgent need of new options and I look forward to using this new therapy that may extend survival for appropriate patients.”

In the Phase 2 BRIGHT 1003 trial, 116 patients with previously untreated de novo or secondary AML who were not eligible to receive intensive chemotherapy were randomized 2:1 to receive DAURISMO plus LDAC or LDAC alone. Of the 78 patients treated with DAURISMO plus LDAC, more than half (51%, 40 patients) had secondary AML, or AML that develops as a result of prior blood/bone marrow conditions or previous anticancer therapy.

Eleven of the 40 patients with secondary AML received prior treatment with a hypomethylating agent; historically, the prognosis is poor for these patients and treatment options have been limited to clinical trials or palliative care.

The most frequently (≥20%) reported adverse reactions in patients receiving DAURISMO were anemia (45.2%), hemorrhages (45.2%), febrile neutropenia (35.7%), nausea (35.7%), decreased appetite (33.3%), fatigue (30.9%), muscle spasms (30.9%), thrombocytopenia (30.9%), pyrexia (29.7%), diarrhea (28.5%), pneumonia (28.5%), dysgeusia (26.1%), oedema peripheral (26.1%), constipation (25.0%), abdominal pain (25.0%), rash (25.0%), dyspnea (25.0%) vomiting (21.4%), and weight decreased (20.2%).

The most frequently reported adverse reactions leading to dose reductions in patients receiving DAURISMO were muscle spasms (4.7%), fatigue (3.5%), febrile neutropenia (3.5%), anemia (2.3%), thrombocytopenia (2.3%), and electrocardiogram QT prolonged (2.3%).

The most frequently reported adverse reactions leading to permanent discontinuation in patients receiving DAURISMO were pneumonia (5.9%), febrile neutropenia (3.5%), and nausea (2.3%).1

DAURISMO™ (glasdegib)

DAURISMO is a once-daily oral Hedgehog pathway inhibitor, taken in combination with LDAC. In the EU, DAURISMO is approved in combination with LDAC for the treatment of newly diagnosed (de novo or secondary) acute myeloid leukemia (AML) in adult patients who are not candidates for standard chemotherapy.

In the U.S. and Canada, DAURISMO is approved in combination with LDAC for the treatment of newly diagnosed AML in adult patients who are 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy.

IMPORTANT DAURISMO™ (Glasdegib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

WARNING: EMBRYO-FETAL TOXICITY: DAURISMO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. DAURISMO is embryotoxic, fetotoxic, and teratogenic in animals.

Conduct pregnancy testing in females of reproductive potential prior to initiation of DAURISMO treatment.

Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose.

Advise males of the potential risk of DAURISMO exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose to avoid potential drug exposure.

Blood Donation: Advise patients not to donate blood or blood products while taking DAURISMO and for at least 30 days after the last dose, because their blood or blood products might be given to a female of reproductive potential.

QTc Interval Prolongation: Patients treated with DAURISMO can develop QTc prolongation and ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia. Of the 98 evaluable patients treated with DAURISMO 100 mg in combination with low-dose cytarabine in the clinical trial, 5% were found to have a QTc interval greater than 500 ms and 4% of patients had an increase from baseline QTc greater than 60 ms.

The clinical trial excluded patients with baseline QTc of greater than 470 ms or with a history of long QT syndrome or uncontrolled cardiovascular disease. Monitor electrocardiograms (ECGs) and electrolytes.

Concomitant use of DAURISMO with drugs known to prolong the QTc interval and CYP3A4 inhibitors may increase the risk of QTc interval prolongation.

In patients with congenital long QT syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring is recommended.

Interrupt DAURISMO if QTc interval is >500 ms and discontinue permanently for patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

Adverse Reactions: Most common adverse reactions associated with DAURISMO (incidence ≥20%) were anemia (43%), fatigue (36%), hemorrhage (36%), febrile neutropenia (31%), musculoskeletal pain (30%), edema (30%), thrombocytopenia (30%), nausea (29%), dyspnea (23%), decreased appetite (21%), dysgeusia (21%), mucositis (21%), constipation (20%), and rash (20%).

Drug Interactions: Co-administration with strong CYP3A4 inhibitors increased DAURISMO plasma concentrations, which may increase the risk of adverse reactions including QTc interval prolongation.

Consider alternative therapies that are not strong CYP3A4 inhibitors during treatment with DAURISMO and monitor patients for increased risk of adverse reactions including QTc interval prolongation.

Strong and moderate CYP3A4 inducers should be avoided due to decreased DAURISMO plasma concentrations, which may reduce efficacy.

If concomitant use of moderate CYP3A4 inducers cannot be avoided, increase the DAURISMO dosage to 200 mg once daily (if the patient is taking 100 mg) and 100 mg once daily (if the patient is taking 50 mg) as tolerated.

Co-administration of DAURISMO with QTc-prolonging drugs may increase the risk of QTc interval prolongation. Avoid co-administration of QTc-prolonging drugs with DAURISMO or replace with alternative therapies.

If co-administration of a QTc-prolonging drug is unavoidable, monitor patients for increased risk of QTc interval prolongation.”
https://www.pfizer.com/news/press-release/press-release-detail/european-commission-approves-daurismotmtm-glasdegib-certain

Roche’s ENSPRYNG®️ approved in Japan for adults and children with neuromyelitis optica spectrum disorder

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Roche’s ENSPRYNG®️ approved in Japan for adults and children with neuromyelitis optica spectrum disorder

June 29, 2020: “Roche announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved ENSPRYNG® (satralizumab) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including NMO, for aquaporin-4 antibody (AQP4-IgG) seropositive adults and children.

ENSPRYNG demonstrated robust efficacy and significantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as an add-on therapy to baseline immunosuppressant therapy (IST), and is dosed subcutaneously every four weeks.

NMOSD is commonly associated with pathogenic antibodies (AQP4-IgG) that target and damage a specific cell type, called astrocytes, resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain.

AQP4-IgG antibodies are detectable in the blood serum of around 70-80% of NMOSD patients, and these patients tend to experience a more severe disease course.

Related News: Roche’s satralizumab results in adults and adolescents with neuromyelitis optica spectrum disorder

Although most cases of NMOSD can be confirmed through a diagnostic test, up to 30% of people living with the condition are still frequently misdiagnosed with multiple sclerosis.

“Today’s approval in Japan is the first for ENSPRYNG in Asia, providing a new treatment option to help reduce NMOSD relapses that cause irreversible disability, such as vision loss and paralysis,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Japan has a high prevalence of NMOSD in both adults and children, but limited approved treatment options.

ENSPRYNG offers robust efficacy, is well-tolerated, and is the first and only approved therapy targeting the interleukin-6 (IL-6) receptor given subcutaneously every four weeks.”

ENSPRYNG is a humanised monoclonal antibody that targets the IL-6 receptor, believed to play a key role in the inflammation that occurs in people with NMOSD.

ENSPRYNG was designed by Chugai Pharmaceutical Co., a member of the Roche group, using novel antibody recycling technology.

Compared to conventional technology, this allows for longer duration of antibody circulation and maximum inhibition of IL-6 signalling, while minimising safety risks in a chronic disease setting. 

People with NMOSD experience unpredictable, severe relapses directly causing cumulative, irreversible neurological damage and disability.

Preventing relapses through early treatment can have a positive impact on preventing disability and is the primary goal for NMOSD disease management.

ENSPRYNG was recently approved in Canada under priority review, as a monotherapy or as an add-on therapy to baseline IST, for the treatment of NMOSD in adult and adolescent patients who are AQP4-IgG seropositive.

In October 2019, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) accepted the marketing applications for ENSPRYNG for the treatment of NMOSD.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation and the FDA decision are expected in 2020. In April 2020, China’s Centre for Drug Evaluation (CDE) accepted a licensing application for ENSPRYNG.

The approval of ENSPRYNG in Japan is based on data including the two pivotal Phase III studies, SAkuraStar and SAkuraSky, evaluating the efficacy and safety of ENSPRYNG as a monotherapy and as an add-on therapy to baseline IST, respectively.

  • In the overall population, a reduction in the risk of relapse was observed in both pivotal studies:
    • In SAkuraSky, the risk of relapse was reduced by 62% (HR, 0.38; 95% CI, 0.16–0.88; p=0.0184) with ENSPRYNG, compared to placebo (both treatment arms as an add-on therapy to baseline IST)
    • In SAkuraStar, the risk of relapse was reduced by 55% (HR, 0.45; 95% CI, 0.23–0.89; p=0.0184) with ENSPRYNG monotherapy, compared to placebo
  • In the pre-specified subgroup of AQP4-IgG seropositive patients, a reduction in the risk of relapse was observed in both pivotal studies:
    • In SAkuraSky, the risk of relapse was reduced by 79% (HR, 0.21; 95% CI, 0.06–0.75) with ENSPRYNG, compared to placebo (both treatment arms as an add-on therapy to baseline IST)
    • In SAkuraStar, the risk of relapse was reduced by 74% (HR, 0.26; 95% CI, 0.11–0.63) with ENSPRYNG monotherapy, compared to placebo
  • Overall, the proportion of patients with serious adverse events was similar between the ENSPRYNG and placebo groups in both studies.

    A lower rate of infections (including serious infections) was observed in patients treated with ENSPRYNG compared with the placebo group.

    The safety profile in longer term follow up is consistent with the double-blind period.”
    https://www.roche.com/media/releases/med-cor-2020-06-29.htm
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