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EMA Accepts Arvelle Therapeutics’ MAA for Cenobamate for the Adjunctive Treatment of Focal-Onset Seizures in Adults

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EMA Accepts Arvelle Therapeutics’ MAA for Cenobamate for the Adjunctive Treatment of Focal-Onset Seizures in Adults

On 26-Mar-2020, SK Biopharmaceuticals Co., Ltd. announced the “European Medicines Agency (EMA) acceptance of Arvelle Therapeutics’ Marketing Authorization Application (MAA) for cenobamate, an anti-epileptic drug (AED) for the adjunctive treatment of focal-onset (partial-onset) seizures in adults.”

Background of agreement:

“In 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics to develop and commercialize cenobamate in Europe. Acceptance of the MAA confirms that the submission is complete and begins the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP).”

Mechanism of action:

“While the precise mechanism by which cenobamate exerts its therapeutic effect is unknown, cenobamate is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents and as a positive allosteric modulator of the γ‑aminobutyric acid (GABAA) ion channel.”

Clinical trial:

“The MAA is based on results from a global clinical trial program conducted by SK life science, the U.S. subsidiary of SK Biopharmaceuticals. The clinical trial program includes two global, randomized, double-blind, placebo-controlled studies and a large, global, multi-center, open-label safety study. These three studies enrolled more than 1,900 adults with uncontrolled focal-onset seizures.”

“In the U.S., the drug will be marketed under the brand name XCOPRI® (cenobamate tablets) CV and is expected to be available in the second quarter of 2020. It was discovered and developed by SK Biopharmaceuticals and SK life science”

https://www.skbp.com/eng/news/view.do?boardCode=BDCD0002&boardSeq=486&currentPage=1&search=

CHMP gives Sanofi positive opinion for Sarclisa for the treatment of relapsed and refractory multiple myeloma

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CHMP gives Sanofi positive opinion for Sarclisa for the treatment of relapsed and refractory multiple myeloma

On 27-Mar-2020, Sanofi announced that “The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sarclisa® (isatuximab).

The CHMP recommends Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.”

“The European Commission (EC) will review the CHMP recommendation and a final decision on the Marketing Authorisation Application for Sarclisa in the E.U. is expected in the coming months. Sarclisa has not been approved for commercial use in the E.U. Sarclisa was approved in the US on March 2 in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.”

Results of Phase III trial:

“The CHMP positive opinion is based on data from ICARIA-MM, the first randomized Phase 3 trial to evaluate an anti-CD38 monoclonal antibody (mAB) in combination with pom-dex. In the ICARIA-MM study, Sarclisa added to pom-dex (Sarclisa combination therapy; n=154) demonstrated a statistically significant improvement of progression-free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone (n=153; HR 0.596, 95% CI: 0.44-0.81, p=0.0010). Sarclisa combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone (60.4% vs. 35.3%, p<0.0001). In additional analyses, Sarclisa combination therapy compared to pom-dex alone showed a treatment benefit consistent across select subgroups reflective of real-world practice, including patients with high-risk cytogenetics, those aged 75 years and older, patients with renal insufficiency, and patients who were refractory to lenalidomide”

The adverse event observed in the Phase III trial:

“The most common adverse reactions (all grades occurring in 20% or more of patients) in patients who received Sarclisa combination therapy were neutropenia (96%), infusion-related reactions (39%), pneumonia (31%), upper respiratory tract infection (57%) and diarrhoea (26%). Serious adverse reactions that occurred in more than 5% of patients who received Sarclisa combination therapy included pneumonia (25.3%) and febrile neutropenia (12.3%). Permanent discontinuation of Sarclisa combination therapy due to an adverse reaction (Grades 3-4) occurred in 7% of patients, and 3% of patients discontinued due to an infusion-related reaction.”
https://www.sanofi.com/en/media-room/press-releases/2020/2020-03-27-07-05-00

Detect COVID-19 in as little as 5 minutes-Abbott’s new diagnostic kit

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Detect COVID-19 in as little as 5 minutes-Abbott’s new diagnostic kit

On 27-Mar-2020, “Abbott has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes.”

It can be used in physicians’ office or urgent care clinics

“The new Abbott ID NOW COVID-19 test runs on Abbott’s ID NOWTM platform—a lightweight box (6.6 pounds and the size of a small toaster) that can sit in a variety of locations.”

“Abbott is planning to deliver 50,000 ID NOW COVID-19 tests per day, beginning next week, to the U.S. healthcare system.”

“This comes on the heels of our announcement last week of the availability of the Abbott RealTime SARS-CoV-2 EUA test under FDA EUA, which runs on m2000 RealTime molecular system for centralized lab environments. Combined with ID NOW, Abbott expects to produce about 5 million tests in April.”

“When not being used for COVID-19 testing, ID NOW is the leading molecular point-of-care platform for Influenza A&B, Strep A and respiratory syncytial virus (RSV) testing. Our platform holds the largest molecular point-of-care footprint in the U.S. and is already widely available in physicians’ offices, urgent care clinics, and hospital emergency departments across the country.”

How does it work?

“Molecular testing technologies help detect the presence of a virus by identifying a small section of the virus’ genome, then amplifying that portion until there’s enough for detection. This process can cut testing wait time from hours, if not days, to as little as five minutes for positive results and 13 minutes for negative results.”

It is important to note that the virus causing COVID19 is an RNA virus.

“The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.”

Novartis and life sciences companies commit expertise and assets to the fight against COVID-19 pandemic alongside Bill & Melinda Gates Foundation

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Novartis and life sciences companies commit expertise and assets to the fight against COVID-19 pandemic alongside Bill & Melinda Gates Foundation

On 26-Mar-2020, Novartis and a consortium of life sciences companies announced an important collaboration to accelerate the development, manufacture and delivery of vaccines, diagnostics, and treatments for COVID-19 in response to the pandemic. 

Vas Narasimhan, CEO of Novartis, said, “We feel a deep shared responsibility to see if there are specific areas where collaboration across the life sciences industry and the Bill & Melinda Gates Foundation can accelerate solutions to this pandemic.

In addition to the individual contributions, companies are already making, collective action is critical to ensure any promising studies into vaccines, drugs, and diagnostics are quickly scaled to people around the world who are affected by this pandemic.”

” As a first step, 15 companies have agreed to share their proprietary libraries of molecular compounds that already have some degree of safety and activity data – with the COVID-19 Therapeutics Accelerator launched by the Gates Foundation, Wellcome, and Mastercard two weeks ago to quickly screen them for potential against COVID-19. Successful hits would move rapidly into in vivo trials in as little as two months.”

” Companies participating in the collaboration include BD, bioMérieux, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck (known as MSD outside the U.S. and Canada), Merck KGaA, Novartis, Pfizer, and Sanofi.”
https://www.novartis.com/news/media-releases/novartis-and-life-sciences-companies-commit-expertise-and-assets-fight-against-covid-19-pandemic-alongside-bill-melinda-gates-foundation

Short note on Plasma therapy- a new approach to treat novel coronavirus (COVID19)

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Short note on Plasma therapy- a new approach to treat novel coronavirus (COVID19)

It is reported in many reports that china has used plasma to treat coronavirus infected patients and achieved success in many patients. Plasma is taken from those individuals who have recovered from this illness.

The liquid portion of blood that remains after red blood cells(RBCs) white blood cells (WBCs), platelets and other cellular components are removed.

Plasma= Blood- Cellular component.

Blood from people who have recovered from Coronavirus disease can be a rich source of antibodies.

Plasma is separated from donor blood and tested for various diseases such as Hepatitis and HIV and used as a source of antibodies against coronavirus.

The strategy has also been attempted with mixed results against viral infections such as H1N1 influenza, SARS and MERS. It should be noted that SARS and MERS are also caused by virus belongs to the coronavirus family.

Many patients got benefited while some have not and physicians have no good idea of why. Yet plasma-based drugs can provide a crucial stop-gap during an emerging pandemic like COVID-19 while therapies and vaccines are being developed.

Let us have a brief Idea about immunity and antibodies to have a better understanding of plasma therapy for COVID19.

There are three types of immunity:

Innate immunity: It can be considered a general immune system.
For example, it ensures that bacteria entering the skin from a small. a wound is detected and partially killed on the spot within a few hours.

It is the first line of defence of the body.

Three main components of the innate immune system.
Skin and all mucous membranes in the body openings such as nose, mouth, vagina etc
Defence cell- while blood cells (leukocytes)
Various elements in the blood and body fluids such as the complement system.

Adaptive Immunity: It is considered a specialized immune system. 

When the first line of protection of the body-the innate immune system-is ineffective in killing the pathogens, the unique adaptive immune response sets in after around four to seven days

This means adaptive defence takes longer but it targets more precisely the pathogen.

It can remember the invader (antigen) and acts specifically against certain antigens. If there is contact again with an antigen that is already known, the defence response can then be faster.

The adaptive immune system produces memory cells.
This is why you can only get a few illnesses only once in your life because afterwards your body becomes “immune.”
Components of Adoptive immune system:
T Lymphocyte
B Lymphocyte
antibodies
cytokines

B cell secrets the antibodies which are soluble protein and quite an antigen/pathogen-specific. This line of defence creates the antibodies in the blood of an individual who survived the COVID19.

Passive immunity: It is “borrowed” from another source and it lasts for a short period.
Breastfeeding mother transfers certain antibodies to the baby which protect the baby from certain pathogens.

Plasma therapy for COVID19 falls under this category.

Few important points which are giving hope for plasma-antibody studies in the treatment of COVID19.

“Convalescent plasma or immunoglobulins (antibodies) have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone”

“In 2014, WHO recommended the use of convalescent plasma collected from patients who had recovered from Ebola virus disease as an empirical treatment during outbreaks”

“A protocol for the use of convalescent plasma in the treatment of Middle East respiratory syndrome coronavirus was established in 2015. In terms of patients with pandemic 2009 influenza A H1N1 (H1N1pdm09) virus infection, a prospective cohort study by Hung and colleagues showed a significant reduction in the relative risk of mortality (odds ratio 0·20 [95% CI 0·06–0·69], p=0·01) for patients treated with convalescent plasma.”

“FDA is allowing the use of plasma but the licensed physician must request the Emergency IND (Investigational new drug application) and obtain the COVID-19 convalescent plasma from a blood centre.”

convalescent plasma can be a promising treatment for COVID19 but this kind of therapy has not worked in many illnesses

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30141-9/fulltext
https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds

Coronavirus: COVID-19 and information Source

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COVID-19: The full form of this disease is Coronavirus Infectious Disease 2019 which is caused by Coronavirus.

Coronavirus: It’s named that because it has a set of spikes that looks like a crown. The word corona means crown in Latin. 

The coronavirus belongs to a family of viruses that can cause many symptoms such as pneumonia, fever, breathing difficulty, throat and lung infection. These viruses are common worldwide in animals but very few cases have been known to affect humans.

Three groups of coronaviruses exist:
Group 1 (HCoV-229E and HCoV-NL63)
Group 2 (HCoVOC43 and HCoV-HKU1),
Group 3 (no human CoVs as yet).

The term 2019 novel coronavirus was used by the World Health Organization (WHO) to refer to a coronavirus which affected the lower respiratory tract of pneumonia patients in Wuhan, China on 29 December 2019

“severe acute respiratory syndrome coronavirus 2 ” is the name announced for the virus responsible for COVID-19 (previously known as “2019 novel coronavirus”) by International Committee on Taxonomy of Viruses (ICTV). In short, it is called as SARS-CoV-2.

Coronaviruses are enveloped single-stranded RNA viruses and zoonotic. RNA virus uses RNA (ribonucleic acid) as genetic material. Other examples of RNA virus are Ebola virus disease, SARS, COVID-19, rabies, common cold, influenza, hepatitis C, hepatitis E, West Nile fever, polio and measles.

The genome size of coronaviruses ranges from 27-34 kilobases(approx).

SARS-CoV and MERS-CoV are members of the coronavirus family.

“Laboratory results also indicated that SARS-CoV-2 is similar to some of the beta (β) coronaviruses genera identified in bats, which is situated in a group of SARS/SARS-like CoV”.

Many domestic and wild animals can serve as hosts for coronaviruses, including camels, cattle, cats and bats.

Animal coronaviruses generally are not known to spread among humans.

There are exceptions, such as SARS and MERS, which are transmitted by cough or sneezing primarily by close contact with infected people by respiratory droplets.

The trouble occurs when the body discovers a virus it hasn’t seen before. This is generally the case for viruses that reside under normal circumstances in animals or birds, e.g. pigs, chickens, and bats. 

These viruses can sometimes “spill over” into humans, causing novel diseases. 

One such illness is COVID-19. It is assumed that the virus for it originated in bats.

Research to combat coronavirus:

There is no approved drug/vaccine for treatment coronavirus but many drugs and treatment options are being evaluated:

Remdesivir:

It works by premature termination of RNA transcription and has in-vitro activity against SARS-CoV-2 and in-vitro and in-vivo activity against related beta coronaviruses.

registered clinical trial:
https://clinicaltrials.gov/ct2/show/NCT04280705
https://clinicaltrials.gov/ct2/show/NCT04292899
https://clinicaltrials.gov/ct2/show/NCT04292730

Hydroxychloroquine and Chloroquine

Hydroxychloroquine and chloroquine are used orally for the treatment of malaria and certain inflammatory conditions. 

” Both drugs have in-vitro activity against SARS-CoV, SARS-CoV-2, and other coronaviruses, with hydroxychloroquine having relatively higher potency against SARS-CoV-2″

Lopinavir-ritonavir: These medications are HIV protease inhibitors. It is used for treatment and prevention of HIV/AIDS
there are many studies related to coronavirus
you can follow the below link to US FDA registered studies.
https://clinicaltrials.gov/ct2/results?cond=&term=Corona+Virus&cntry=&state=&city=&dist=
https://clinicaltrials.gov/ct2/results?cond=&term=COVID&cntry=&state=&city=&dist=

Structure of the coronavirus:
https://www.sciencedirect.com/topics/neuroscience/coronavirus

A best and most reliable source for COVID-19 information:

WHO:  
https://www.who.int/health-topics/coronavirus#tab=tab_1

CDC: Centre for Disease Control and Prevention:
https://www.cdc.gov/coronavirus/2019-ncov/index.html

European Centre for Disease Prevention and Control
https://www.ecdc.europa.eu/en/novel-coronavirus-china/questions-answers

Worldometer:
https://www.worldometers.info/coronavirus/

Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia

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Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia

March 09, 2020- Roche announced that “we are working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), to evaluate the safety and efficacy of Actemra®/RoActemra® (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.”

“This is the first global study of Actemra/RoActemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including the US. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.”

“To date, several independent clinical trials are exploring the efficacy and safety of Actemra/RoActemra for the treatment of patients with COVID-19 pneumonia. Actemra/RoActemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on March 3, 2020.”

“However, this new trial is vital because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra/RoActemra in the treatment of patients suffering from COVID-19. In addition, Actemra/RoActemra is not currently approved for this use by any health authorities, including the US Food and Drug Administration (FDA).”

https://www.roche.com/media/releases/med-cor-2020-03-19.htm

Vivli to launch a portal for sharing data from COVID-19 trials

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Vivli to launch a portal for sharing data from COVID-19 trials

In a visible sign of data sharing leadership, Vivli, the Center for Clinical Research Data, has committed to serving the open science community through the launch of a COVID-19 portal for sharing of completed interventional treatment trial data. All member and user fees would be waived for sharing and access.”

“Today, we are announcing this initiative as it is so important for the entire data-sharing community to come together and do everything we can to share the data from these completed clinical trials,” said Rebecca Li, Vivli Executive Director. “Sharing data transparently and openly is the best way to honour the decisions made by participants in these trials and bring us closer to safe and effective treatments and vaccines.”

“Vivli has been at the forefront of data sharing and I am delighted to see us do all that we can to advance the knowledge around the COVID-19 pandemic,” Sim said. “Vivli was created to make data sharing practical and easy to do. COVID-19 trials should be made open to all researchers so that no stone is left unturned in reviewing and analyzing the data.”

ttps://vivli.org/vivli-to-launch-a-portal-for-sharing-data-from-covid-19-trials/

Novartis will donate up to 130 million doses of hydroxychloroquine to support the global COVID-19 pandemic response

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Novartis will donate up to 130 million doses of hydroxychloroquine to support the global COVID-19 pandemic response

March 20, 2020 – “Novartis announced that its commitment to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response. Hydroxychloroquine and a related drug, chloroquine, are currently under evaluation in clinical trials for the treatment of COVID-19. Novartis is supporting ongoing clinical trial efforts and will evaluate needs for additional clinical trials.”

“When supported for use in COVID-19 infected patients by regulatory authorities, Novartis intends to donate up to 130 million 200 mg doses by the end of May, including its current stock of 50 million 200 mg doses. The company is also exploring further scaling of capacity to increase supply and is committed to working with manufacturers around the world to meet global demand.”

“The commitment announced today builds on the previously announced commitments of a USD 20 million Novartis COVID-19 Response Fund, drug discovery collaboration efforts, support of clinical trials for existing Novartis medicines, and the Sandoz commitment to maintaining stable prices on a basket of essential medicines that may help in the treatment of COVID-19.”

“Novartis intends to work closely with other manufacturers to scale up production of hydroxychloroquine as necessary to support global supply, and encourages industry, governments and international institutions to ensure adequate global supply of medications to treat COVID-19 patients.”

https://www.novartis.com/news/media-releases/novartis-commits-donate-130-million-doses-hydroxychloroquine-support-global-covid-19-pandemic-response

CryoLife receives CE mark for E-vita Open Neo hybrid stent graft system for the treatment of aortic arch disease

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CryoLife receives CE mark for E-vita Open Neo hybrid stent graft system for the treatment of aortic arch disease

March 5, 2020: CryoLife has announced that it has received CE mark for E-vita Open Neo, a hybrid stent graft system for the treatment of aortic arch disease. Aortic arch disease encompasses both aortic aneurysms and aortic dissections that occur unexpectedly and unwarned. Approximately 7,000 patients are diagnosed annually in Europe, the Middle East and Africa for the thoracic aortic arch disease.

Many patients with either an aneurysm or dissection in the aortic arch also have a dissected or aneurysmal thoracic aorta that descends. Such two conditions are often treated in a two-stage procedure — one for repairing the arch and the other for repairing the descending thoracic aorta.

The company’s hybrid stent-graft technology, which includes the E-vita Open Neo and the E-vita Open Plus, allows for a one-stage treatment of this condition by incorporating surgical arch repair and thoracic endovascular decay. The E-vita Open Neo is anticipated to be used regularly in conjunction with Jotec’s thoracic stent graft product, E-nya.
https://vascularnews.com/ce-mark-for-e-vita-open-neo-hybrid-stent-graft/

FDA grant Approval For Allergan’s durysta (Bimatoprost Implant) for Open-Angle Glaucoma Or Ocular Hypertension Patients

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FDA grant Approval For Allergan’s durysta (Bimatoprost Implant) for Open-Angle Glaucoma Or Ocular Hypertension Patients

March 5, 2020: Allergan announced that the U.S. FDA has approved the company’s New Drug Application (NDA) for DURYSTA™ (bimatoprost implant) 10 mcg for intracameral administration. With this approval, DURYSTA™ becomes the first intracameral, biodegradable sustained-release implant indicated to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

The FDA approval is based on results from the two 20-month (including 8-month extended follow up) Phase 3 ARTEMIS studies evaluating 1,122 subjects on the effectiveness and safety of DURYSTA™ versus twice-daily topical timolol drops, an FDA accepted comparator for the registrational clinical trials, in patients with OAG or OHT. In the two Phase 3 ARTEMIS studies, DURYSTA™ reduced IOP by about 30 percent from baseline over the 12-week primary value period, meeting the predefined criteria for non-inferiority to the study comparator. With the launch of DURYSTA™, Allergan proudly expands availability of the Allergan EyeCue®, a proven reimbursement service for the eye care professionals in order to facilitate patient benefit verification, savings program enrollment for eligible patients, and prior authorization (PA) assistance for Allergan Eye Care products.

About DURYSTA™DURYSTA™ is a prostaglandin analogue indicated for the reduction of IOP in the patients with OAG or OHT. DURYSTA™ is an ophthalmic drug delivery system for a single intracameral administration of the biodegradable implant containing 10 mcg bimatoprost. DURYSTA™ should not be re-administered to an eye that received a prior DURYSTA™. DURYSTA™ is preloaded into a single-use applicator to assist the administration of the biodegradable implant directly into the anterior chamber of the eye.

INDICATIONS AND USAGE: DURYSTA™ (bimatoprost implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

IMPORTANT SAFETY INFORMATION Contraindications: DURYSTATM is contraindicated in patients with: confirmed or suspected ocular or periocular infections; corneal endothelial dystrophy (e.g., Fuchs ‘ dystrophy); previous corneal transplantation or endothelial cell transplantation (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [ DSAEK ]); absent or ruptured posterior lens capsule, due to the risk of the implant migration into posterior segment; hypersensitivity to bimatoprost or to any other components of the product.

Warnings and Precautions: The presence of DURYSTA™ implants has been associated with the corneal adverse reactions and increased risk of the corneal endothelial cell loss. DURYSTATM administration should be limited to one single implant per eye with no retreatment. Caution should be taken in patients with limited corneal endothelial cell reserve when prescribing DURYSTATM.Adverse reactions: In controlled studies, 27 per cent of patients reported the most common ocular adverse reaction being conjunctival hyperemia. Other common adverse reactions included foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye irritation, increased intraocular pressure, corneal endothelial cell loss, blurred vision, iritis, and headache in 5 per cent of patients.
https://www.allergan.com/News/Details/2020/03/Allergan%20Receives%20FDA%20Approval%20for%20DURYSTA%20bimatoprost%20implant%20the%20First%20and%20Only%20Intracameral%20Biode

U.S. Food and Drug Administration grants Orphan Drug Designation to TG Therapeutics for Umbralisib for the Treatment of Follicular Lymphoma

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U.S. Food and Drug Administration grants Orphan Drug Designation to TG Therapeutics for Umbralisib for the Treatment of Follicular Lymphoma

March 05, 2020: TG Therapeutics announced that the U.S.FDA granted orphan drug designation to umbralisib, the Company’s investigational dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of patients with follicular lymphoma (FL).

“In the UNITY-NHL Phase 2b registration controlled clinical trial, Umbralisib is tested across several types of lymphoma.

The UNITY-NHL trial FL cohort is designed to determine the safety and efficacy of umbralisib in FL patients who have undergone at least two prior therapy lines including a monoclonal antibody anti-CD20 and an alkylating agent.

The Company announced in October 2019 that the FL cohort reached the primary endpoint of the overall response rate (ORR), and the Company introduced a rolling submission of a New Drug Submission (NDA) to the US in January.

Administration of Food and Drugs (FDA) for umbralisib as a treatment for patients with previously diagnosed marginal zone lymphoma (MZL) and FL. For the treatment of patients with all three forms of MZL, the FDA previously granted umbralisib orphan drug designation: nodal, extranodal, and splenic MZL.”

The U.S. grants orphan drug designation. “FDA on drugs and biologics identified as those intended for safe and effective treatment, diagnosis or prevention of rare diseases/disorders affecting fewer than 200,000 people in the United States. The classification of orphan drugs includes other benefits that can include tax deductions against the expense of clinical trials and exemptions for prescription drug users. When, eventually, a product with an orphan drug label earns the first FDA approval for the disease for which it has that designation, the product is entitled to exclusivity for orphan drugs.”

“Follicular lymphoma (FL) is usually a slow-growing or indolent type of non-Hodgkin lymphoma (NHL) which results from B-lymphocytes, making it a lymphoma of the B-cells. Follicular lymphoma is typically not curable, and it is a chronic condition. Patients with this form of lymphoma will live with it for many years. With an estimated occurrence of about 15,000 newly diagnosed patients in the United States, FL is the most common indolent lymphoma, accounting for about 20 per cent of all NHL cases.”
https://fda.einnews.com/pr_news/511287565/tg-therapeutics-receives-orphan-drug-designation-for-umbralisib-from-the-u-s-food-and-drug-administration-for-the-treatment-of-follicular-lymphoma

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