CLINSQUARE: CLINICAL RESEARCH COURSES
Thursday, May 29, 2025
CLINSQUARE: Clinical Rsearch Courses by LIFEPRONOW
Home Blog Page 27

Novartis peer-reviewed safety and tolerability data further strengthens Kesimpta’s benefit-risk profile

admin
-
0
Novartis peer-reviewed safety and tolerability data further strengthens Kesimpta’s benefit-risk profile

March 2, 2022: “Novartis announced that new data from the ALITHIOS open-label extension study was published in the peer-reviewed Multiple Sclerosis Journal.

The data showed that with up to 3.5 years of treatment with Kesimpta® (ofatumumab), no incidences of opportunistic infections were reported, and observed COVID-19 infections showed no evidence of an increase in incidence or severe outcomes in adults with relapsing forms of multiple sclerosis (RMS).

Mean immunoglobulin G (IgG) levels remained stable and immunoglobulin M (IgM) levels remained above the lower limit of normal in most patients.

The overall incidence of serious infections was low and no new safety risks were identified.

This study, which included 1,969 RMS patients, provides a robust picture of the continuous safety data for Kesimpta.

“The cumulative safety data suggest that treatment with Kesimpta over an extended period of time is well tolerated in adults with RMS and support the long-term use of Kesimpta in all RMS patients, including early MS patients,” said Lykke Hinsch Gylvin, Neuroscience Global Medical Franchise Head, Novartis Pharmaceuticals.

“While low serum immunoglobulin observed with anti-CD20 therapies have historically been linked with an apparent risk of serious infection, immunoglobulin data seen with Kesimpta over extended exposure showed that mean Ig levels remained within reference ranges with a low overall incidence of serious infection, including COVID-19.

These data give confidence to people living with MS and their prescribing physicians, and further support Kesimpta as a potential first-choice treatment option for RMS.”

About Kesimpta® (ofatumumab)
Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with RMS.

It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously.

Initial doses of Kesimpta are given at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional.

As shown in preclinical studies, Kesimpta is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion.

The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen.

Once-monthly dosing of Kesimpta also allows faster repletion of B-cells and offers more flexibility.

Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 2015.”

https://www.novartis.com/news/media-releases/novartis-peer-reviewed-safety-and-tolerability-data-further-strengthens-kesimptas-ofatumumab-favorable-benefit-risk-profile-patients-relapsing-multiple-sclerosis

FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments

admin
-
0
FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments

March 01, 2022: ‘The U.S. FDA issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative to facilitate continued advancement in cancer prevention, detection, research, and patient care.

Inspired by medical advancements in the field since 2016, the President’s new goals for this iteration are to reduce the death rate from cancer by at least 50 percent over the next 25 years; to improve the experience of people and their families living with and surviving cancer; and, by doing this and more, to end cancer as we know it today.

“With today’s actions the FDA is recommending important principles that involve addressing inequities, targeting the right treatments to the right patients, speeding progress against the most deadly and rare cancers, and learning from the experience of all patients,” said Richard Pazdur, M.D., Director for the FDA’s Oncology Center for Excellence.

“All of these are tenets of Cancer Moonshot’s mission.”

The first guidance, “Inclusion of Older Adults in Cancer Clinical Trials,” provides recommendations to sponsors and institutional review boards for including older adult patients, aged 65 years and older, in the clinical trials of drugs for the treatment of cancer.

It recommends enrolling older adults in early phase studies of cancer clinical trials, if appropriate, to obtain information that better informs later phase studies.

It also includes recommendations for trial design, recruitment strategies, information collection, and developing and reporting more discrete age groups to encourage enrollment of this historically excluded population.

It is vital to have older adult patients in clinical trials because differences may exist between younger and older patients in drug response and toxicity.

Older adults often have other diseases or conditions and may be taking medications that could impact the efficacy of either the cancer drug or other drugs they are taking and may also impact the incidence and the severity of adverse events.

There could also be important differences in efficacy in older adult patients compared to the younger or general population.

The second guidance for industry “Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics,” provides advice on designing and conducting trials with multiple expansion cohorts that allow for concurrent accrual of patients into different cohorts to assess safety, pharmacokinetics, and anti-tumor activity of first-in human cancer drugs.

Pharmaceutical companies and researchers can use trials with expansion cohort design to assess many different aspects of a drug in a single clinical trial to efficiently expedite the clinical development of the drug.

This guidance provides the FDA’s recommendations regarding: 

  • characteristics of drug products best suited for consideration for development under a multiple expansion cohort trial; 
  • information to include in investigational new drug application submissions to support the design of individual expansion cohorts; 
  • when to interact with FDA on planning and conduct of multiple expansion cohort studies; and 
  • safeguards to protect patients enrolled in these expansion cohort studies.

Finally, the “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics” guidance addresses master protocol design including information on what sponsors should submit to the FDA as part of these trial design approaches.

It also directs how sponsors should interact with the FDA to facilitate efficient review and mitigate risks to patients.

These clinical trials can help expedite the clinical development of a drug to treat cancer because they allow more than one investigational drug or biologic, more than one disease type, or more than one patient population, to be evaluated under a single clinical trial structure.

The standard approach to generating evidence has become more expensive and challenging to execute and, as a result, answers to important clinical questions are often delayed.

Well-designed master protocols can provide answers more quickly and efficiently than traditional clinical trials.

Because of the complexity of these trials and the potential regulatory impact, it’s important that the FDA is providing this guidance on how to conduct well designed trials that protect patient safety and obtain quality data needed to support drug approval.”

https://www.fda.gov/news-events/press-announcements/fda-clinical-trial-guidances-share-biden-administrations-goals-advancing-development-cancer

AZ and Neurimmune close exclusive global collaboration and licence agreement to develop and commercialise NI006

admin
-
0
AZ and Neurimmune close exclusive global collaboration and licence agreement to develop and commercialise NI006

March 01, 2022: “Alexion, AstraZeneca’s Rare Disease group, has closed an exclusive global collaboration and licence agreement with Neurimmune AG for NI006, an investigational human monoclonal antibody currently in Phase Ib development for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), an underdiagnosed, systemic condition that leads to progressive heart failure and high rate of fatality within four years from diagnosis.

Alexion has been granted an exclusive worldwide licence to develop, manufacture and commercialise NI006.

NI006 is an ATTR depleter that specifically targets tissue-deposited, misfolded transthyretin, with the potential to treat patients with advanced ATTR-CM.

NI006 adds a novel and complementary approach to AstraZeneca and Alexion’s pipeline of investigational therapies focused on amyloidosis and strengthens the Company’s broader commitment to addressing cardiomyopathies that can lead to heart failure (HF).

Financial considerations
Under the terms of the agreement, the upfront payment from Alexion to Neurimmune is $30m.

Alexion will make additional contingent milestone payments of up to $730m upon achievement of certain development, regulatory and commercial milestones.

It will also pay low-to-mid teen royalties on net sales of any approved medicine resulting from the collaboration.

Neurimmune will continue to be responsible for completion of the current Phase Ib clinical trial on behalf of Alexion, and Alexion will pay certain trial costs.

Alexion will be responsible for further clinical development, manufacturing and commercialisation following the Phase Ib trial.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/astrazeneca-and-neurimmune-close-deal-for-ni006.html

Singapore medicines regulator world’s first to achieve highest maturity level in WHO classification

admin
-
0
Singapore medicines regulator world’s first to achieve highest maturity level in WHO classification

February 27, 2022: “Out of 28 countries formally assessed by WHO, Singapore is the first to have achieved the highest maturity level (ML 4) in WHO’s classification of regulatory authorities for medical products.

Achieving ML 4 brings Singapore closer to becoming a WHO listed authority, a new scheme that will be operational later this year and will list the world’s regulators of reference.

“This is great recognition of Singapore’s achievement and very good news for the broader region,” said Martin Taylor, WHO Western Pacific Region Director of Health Systems & Services and acting Director for Data, Strategy & Innovation.

“Singapore already helps several neighbouring countries to expedite their medicines assessments and this WHO classification may also encourage other countries and areas to continue strengthening their medicines oversight.”

Regulation of medical products is extremely important for all health systems and for access to quality vaccines, medicines and other health products.

Apart from ensuring the quality, safety and efficacy of medical products, regulatory authorities that function well also perform critical functions such as faster authorization of products and drug safety monitoring after authorization.

WHO’s assessment of regulatory authorities is based on the ‘Global Benchmarking Tool’ – an evaluation tool that checks regulatory functions against a set of more than 260 indicators – covering core regulatory functions such as product authorization, testing of products, market surveillance and the ability to detect adverse events – to establish their level of maturity and functionality.

Regulatory authorities that reach maturity levels 3 and 4 will be considered eligible for inclusion among WHO-listed authorities, after additional evaluation of their performance.

The benchmarking of Singapore’s Health Sciences Authority (HSA) was carried out by a WHO-led team of international experts. In late 2021, WHO conducted a formal evaluation of the Authority and the HSA was found to perform well against the indicators of the Global Benchmarking Tool.

“The Health Sciences Authority of Singapore is honoured to have achieved maturity level 4 in WHO’s recent global benchmarking assessment,” said Dr Choong May Ling, Mimi, Chief Executive Officer, Health Sciences Authority, Singapore.

“This achievement is a significant milestone and affirmation for Singapore as the first WHO Member State to have reached this highest maturity level for our medicines regulatory system.

I believe this achievement will boost public confidence and trust in the system.

I look forward to HSA sustaining our culture of operational excellence and continuous improvement and continuing our strong collaboration with WHO in regulatory systems strengthening.”

Fewer than 30% of the world’s medicines regulatory authorities are considered to have the capacity to perform the functions required to ensure medicines, vaccines and other health products work and do not harm patients.

For that reason, WHO has intensified efforts to bolster the capacity to regulate medical products in all regions and is working to strengthen regulatory networks where the most advanced regulatory authorities can act as lighthouses for regulators with fewer resources or which have not yet reached maturity.

“The core of WHO’s work is to empower countries through support and knowledge sharing so that they can expand access to health services for their populations,” said Mariângela Simão, WHO Assistant Director General for Access to Medicines and Other Health Products.

“If countries want to improve health outcomes, if they want to be able to address health emergencies and expand local production, they first need to be able to ensure access to safe and quality medical products that actually work and benefit patients.”

https://www.who.int/news/item/27-02-2022-singapore-medicines-regulator-world-s-first-to-achieve-highest-maturity-level-in-who-classification

FDA Approves Treatment for Wider Range of Patients with Heart Failure

admin
-
0
FDA Approves Treatment for Wider Range of Patients with Heart Failure

February 24, 2022: “The U.S. FDA approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.

Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes.

Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction.

“Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Norman Stockbridge, M.D., Ph.D., Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research.

“While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure. Coinciding with February’s annual observance of American Heart Month—a reminder for individuals to focus on cardiovascular health—this action will provide physicians another tool to address heart disease.”

Heart failure is a syndrome in which the heart is not meeting the needs of the body, affecting more than 650,000 people in the U.S. each year.

Despite therapies in multiple drug classes, mortality remains high and treatment options for a broader range of patients are needed.

Symptoms of heart failure vary but can include shortness of breath, fatigue and swelling in the legs.

Heart failure becomes more common with age and is the leading cause of hospitalization in people over 65 years old.  

For today’s approval, Jardiance’s safety and effectiveness were evaluated as an adjunct to standard of care therapy in a randomized, double-blind, international trial comparing 2,997 participants who received Jardiance, 10 mg, once daily to 2,991 participants who received the placebo.

The main efficacy measurement was the time to death from cardiovascular causes or need to be hospitalized for heart failure.

Of the individuals who received Jardiance for an average of about two years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared to 17% of the participants who received the placebo.

This benefit was mostly attributable to fewer patients being hospitalized for heart failure.

The side effects in clinical studies with Jardiance for patients with heart failure were generally consistent with side effects for patients with diabetes.

In diabetic patients, the most common adverse events were urinary tract infections and female fungal infections.

Jardiance must not be used in patients who previously have had a serious allergic reaction to it as well as patients on dialysis. 

See the prescribing information for additional information on risks associated with Jardiance.

Jardiance received Priority Review designation for this indication. 

The FDA granted the approval of Jardiance to Boehringer Ingelheim.”

https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-wider-range-patients-heart-failure

Bayer extends clinical development program for finerenone for chronic kidney disease and type 2 diabetes

admin
-
0
Bayer extends clinical development program for finerenone for chronic kidney disease and type 2 diabetes

February 24, 2022: “Bayer announced the initiation of the CONFIDENCE study, a Phase II, three-arm study that will investigate simultaneous initial combination therapy with finerenone and the SGLT2 inhibitor empagliflozin, compared with finerenone alone and empagliflozin alone respectively in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).

The primary objective of the study is to demonstrate that the simultaneous initiation and combined use of finerenone and empagliflozin is superior to either empagliflozin alone, or finerenone alone, in reducing urine albumin-to-creatinine ratio (UACR).

The primary outcome is the relative change from baseline in UACR at 180 days in the combination therapy group vs the monotherapy groups.

“UACR is an important predictor of long-term renal and cardiovascular outcomes in chronic kidney disease and type 2 diabetes patients, with elevated levels indicating worsening kidney damage.

In a post-hoc analysis of the FIDELIO-DKD study, finerenone indicated a reduction in UACR levels with or without an SGLT2 inhibitor at baseline.

An efficient intervention assessed by UACR reduction may provide long-term benefits for patients,” said Rajiv Agarwal, MD, Professor of Medicine, Indiana University School of Medicine and VA Medical Centre, Indianapolis, USA and Chair of the study’s Steering Committee.

“If successful, the results of the CONFIDENCE study could be of great significance to clinicians when considering how to optimize disease management and further delay kidney disease progression, while also providing additional insights into the safety of using these treatments in combination.”

Finerenone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, has been investigated in a broad population of patients with stages 1-4 CKD and type 2 diabetes (T2D) across two completed and published Phase III studies: FIDELIO-DKD and FIGARO-DKD evaluated the effects of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes in patients with CKD and T2D.

The initiation of the Phase II CONFIDENCE study (COmbinatioN effect of FInerenone anDEmpaglifloziN in participants with CKD and T2D using an UACR Endpoint study) builds on the robust Phase III results with finerenone.

“Despite treatment with standard of care, the residual risk for cardiorenal events remains high in patients living with chronic kidney disease and type 2 diabetes.

There is a high unmet need for treatments that can reduce the extensive burden associated with the progression of kidney disease and the connected risk of cardiovascular events,” said Dr. Michael Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance at Bayer’s Pharmaceuticals Division.

“We expect the CONFIDENCE study to extend our clinical insights on finerenone and hope to be able to provide evidence on the potential additive cardiovascular and renal benefits of combination therapy with finerenone and an SGLT2 inhibitor.”

The Phase II CONFIDENCE study will investigate finerenone plus empagliflozin compared with either finerenone or empagliflozin alone in about 870 patients with CKD and T2D.

Patients will be randomized in a 1:1:1 ratio stratified by estimated glomerular filtration rate (eGFR) and UACR at screening and will receive either finerenone (10 or 20 mg once daily) and empagliflozin (10 mg), finerenone (10 or 20 mg) and matching placebo to empagliflozin, or empagliflozin (10 mg) and matching placebo to finerenone.

Based on the positive results of the FIDELIO-DKD Phase III study, finerenone was granted marketing authorization in the European Union and was approved by the U.S. FDA under the brand name Kerendia®.

Finerenone has also been submitted for marketing authorization in multiple other countries worldwide and these applications are currently under review.

About Kerendia®
Kerendia® (finerenone) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that in preclinical studies has been shown to block harmful effects of MR overactivation.

MR overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.

The Phase III study program with finerenone, FINEOVATE, currently comprises five Phase III studies, FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD, and FIONA.

Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III program with finerenone in CKD and T2D comprises two completed and published studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.

FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D. 

FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D.

FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis), including the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest Phase III cardiorenal outcomes clinical trial programme to evaluate the occurrence of progression of kidney disease as well as fatal and nonfatal CV events in >13,000 patients with CKD and T2D. 

The prespecified FIDELITY pooled analysis investigated the efficacy and safety of finerenone across the spectrum of patients with CKD in T2D and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes risk categories) and the effects of finerenone on composite cardiovascular and kidney-specific endpoints.

In November 2021, Bayer announced the initiation of FIONA, a multicenter, randomized, double-blind, placebo-controlled Phase III study, to investigate the efficacy, safety, and pharmacokinetics/pharmacodynamics (PK/PD) of finerenone, in addition to standard of care, in approximately 200 pediatric patients with chronic kidney disease (CKD) and severely increased proteinuria.

In September 2021, Bayer announced the initiation of the Phase III study FIND-CKD, a multicenter, randomized, double-blind, placebo-controlled Phase III study to investigate the efficacy and safety of finerenone in addition to guideline-directed therapy on the progression of chronic kidney disease (CKD) in more than 1,500 patients with non-diabetic chronic kidney disease etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys).

In June 2020, Bayer announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone compared to placebo in more than 5,500 patients with symptomatic heart failure (New York Heart Association class II-IV) with preserved ejection fraction, i.e., a left ventricular ejection fraction of ≥40%. 

The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure (HF) events (defined as hospitalizations for HF or urgent HF visits).”

https://media.bayer.com/baynews/baynews.nsf/id/Bayer-extends-clinical-development-program-finerenone-Phase-II-study-investigating-initial?OpenDocument&sessionID=1645685487

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

admin
-
0
Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

February 23, 2022: “Sanofi and GSK today announce that they intend to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine. 

The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings.

In participants who had received a primary series of an already authorized mRNA or adenovirus vaccine, the Sanofi-GSK booster vaccine induced a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups.

When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels (see Figures 1a and 1b for details).

Thomas Triomphe, Executive Vice President, Sanofi Vaccines, said: “We’re very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine.

The Sanofi-GSK vaccine demonstrates a universal ability to boost all platforms and across all ages.

We also observed robust efficacy of the vaccine as a primary series in today’s challenging epidemiological environment.

No other global Phase 3 efficacy study has been undertaken during this period with so many variants of concern, including Omicron, and these efficacy data are similar to the recent clinical data from authorized vaccines.”

Roger Connor, President of GSK Vaccines, said: “The evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines.

Our adjuvanted protein-based vaccine candidate uses a well-established approach that has been applied widely to prevent infection with other viruses including pandemic flu.

We are confident that this vaccine can play an important role as we continue to address this pandemic and prepare for the post-pandemic period.”

When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units.

For comparison, a panel of sera from volunteers in the same age range who received two doses of an already approved and highly effective mRNA vaccine displayed a GMT of 1653 units, measured simultaneously in the same laboratory. 

Data from the VAT08 efficacy study showed that two doses of Sanofi-GSK vaccine generated an efficacy of 57.9% (95% confidence interval [CI, 26.5, 76.7]) against any symptomatic COVID-19 disease in the seronegative population.

The Sanofi-GSK vaccine provided 100% protection (0 vs 10 cases post-dose 1, 0 vs 4 cases post-dose 2) against severe disease and hospitalizations and 75% (3 vs 11 cases) efficacy against moderate-to-severe disease in seronegative populations.

While sequencing is still in progress, early data indicate 77% efficacy against any Delta variant-associated symptomatic COVID-19 disease, in line with expected  vaccine effectiveness.

Across both studies, the Sanofi-GSK vaccine was well-tolerated in younger and older adults with no safety concerns.  

The companies are in discussions with regulatory authorities, including the US FDA and European Medicines Agency (EMA), and plan to submit the totality of the data generated with this vaccine candidate to support regulatory authorizations.

To evaluate the immunogenicity of the Sanofi-GSK vaccine as a booster, human immune sera samples were tested by Monogram Biosciences [San Francisco, CA] using an FDA-approved standardized pseudovirus neutralization test (pVNT) against the D614G prototype virus.”

https://www.gsk.com/en-gb/media/press-releases/sanofi-and-gsk-to-seek-regulatory-authorization-for-covid-19-vaccine/

FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

admin
-
0
FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

February 23, 2022: “The U.S. FDA authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse.

The condoms, which will be marketed as the One Male Condom, are also indicated as a contraceptive to help reduce the risk of pregnancy and the transmission of STIs during vaginal intercourse.

Before today’s authorization, the FDA had not cleared or approved condoms specifically indicated for anal intercourse.

Unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission.

Consistent and correct condom use has the potential to significantly help decrease the risk of STIs.

While today’s authorization underscores the public health importance of condoms tested and labeled specifically for anal intercourse, all other FDA-cleared condoms can continue to be used for contraception and STI prevention.

It’s important to continue to use condoms consistently and correctly to reduce the risk of STI transmission, including HIV, and to prevent pregnancy.

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse.

The FDA’s authorization of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” said Courtney Lias, Ph.D., director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.

“Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations.

This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster.” 

The One Male Condom is a natural rubber latex sheath that covers the penis. It has three different versions: standard, thin and fitted.

The fitted condoms, available in 54 different sizes, incorporate a paper template to aid in finding the best condom size for each user.

When used during anal intercourse, the One Male Condom should be used with a condom-compatible lubricant.

The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women. All participants were between 18 through 54 years old.  

The study found that the total condom failure rate was 0.68% for anal intercourse and 1.89% for vaginal intercourse with the One Male Condom.

Condom failure rate was defined as the number of slippage, breakage or both slippage and breakage events that occurred over the total number of sex acts performed.

For the One Male Condom, the overall percentage of adverse events was 1.92%.

Adverse events reported during the clinical trial included symptomatic STI or recent STI diagnosis (0.64%), condom or lubricant-related discomfort (0.85%), partner discomfort with lubricant (0.21%) and partner urinary tract infection (0.21%).

The symptomatic STI or recent STI diagnoses observed in the study were self-reported and may be the result of subjects having intercourse without a condom or may have preceded use of the One Male Condom, as STIs were not measured at baseline.

The FDA reviewed the One Male Condom through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing.

When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type.

This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The FDA granted the marketing authorization to Global Protection Corp.”

https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse

GSK announces independent Consumer Healthcare company is to be called Haleon

admin
-
0
GSK announces independent Consumer Healthcare company is to be called Haleon

February 22, 2022: “GlaxoSmithKline plc announced that the new company, to result from the proposed demerger of Consumer Healthcare from GSK in mid-2022, will be called Haleon.

Haleon (pronounced “Hay-Lee-On”) is inspired by the merging of the words ‘Hale’, which is an old English word that means ‘in good health’ and Leon, which is associated with the word ‘strength’.

The new brand identity was developed with input from employees, healthcare practitioners and consumers and will be deployed in more than 100 markets around the world where the business operates.

The creation of Haleon results from a series of successful investments and strategic changes to GSK’s consumer health business over the last 8 years, including integrations of the consumer product portfolios from Novartis and Pfizer.

It is now a highly valuable and focused global business generating annual sales of approximately £10 billion.

As a standalone company, Haleon will be a new world-leader in consumer healthcare, offering a compelling proposition – to bring deep human understanding together with trusted science – to deliver better everyday health with humanity.

Brian McNamara, Chief Executive Officer Designate, Haleon, said: “Introducing Haleon to the world marks another step in our journey to become a new, standalone company. Our name is grounded in our purpose to deliver better everyday health with humanity and to be a world-leader in consumer healthcare.

We are on track to launch Haleon in mid-2022 and our business momentum is strong.

We look forward to updating investors and analysts more on this at our capital markets event at the end of February.”

Emma Walmsley, Chief Executive Officer, GSK, said: “Haleon brings to life years of hard work by many outstanding people to build this new company purely dedicated to everyday health.

Haleon has enormous potential to improve health and wellbeing across the world with strong prospects for growth, and through listing will unlock significant value for GSK shareholders.”

Haleon will have a world-class portfolio of category-leading global brands, including Sensodyne, Voltaren, Panadol and Centrum.

Its brands are trusted by healthcare professionals, customers and people worldwide to improve the health and wellbeing of individuals and their communities.

Demand from the £150 billion consumer healthcare sector is strong, reflecting an increased focus on health and wellness, significant demand from an ageing population and emerging middle-class, and unmet consumer needs.

The business is therefore well-positioned to deliver human health impact and to sustainably grow ahead of the market in the years to come.

The new name was announced as part of a global celebration for all of the people working in GSK Consumer Healthcare earlier today. 

Employees from around the world had the opportunity to engage with the new name and brand identity which seeks to bring to life the company’s purpose and growth ambitions.

The name was also announced in advance of GSK hosting a Consumer Healthcare Capital Markets Day for investors and analysts on Monday 28 February, to provide details on the overall strategy, capabilities and operations of Haleon, including detailed financial information and growth ambitions of the business.

For prospective investors, Haleon will offer attractive organic sales growth, operating margin expansion and consistent high cash generation.”

https://www.gsk.com/en-gb/media/press-releases/gsk-announces-independent-consumer-healthcare-company-is-to-be-called-haleon/

AZ progresses Ambition Zero Carbon programme with Honeywell partnership to develop next-generation respiratory inhalers

admin
-
0
AZ progresses Ambition Zero Carbon programme with Honeywell partnership to develop next-generation respiratory inhalers

February 22, 2022: “AstraZeneca and Honeywell will partner to develop next-generation respiratory inhalers using the propellant HFO-1234ze, which has up to 99.9% less Global Warming Potential (GWP) than propellants currently used in respiratory medicines.

Today’s announcement coincides with the publication of the Company’s annual Sustainability Report and demonstrates progress on its flagship sustainability programme, Ambition Zero Carbon.

The Report also shows that the entirety of AstraZeneca’s imported electricity now comes from renewable sources and that the Company has achieved a 59% reduction in its Scope 1 and 2 greenhouse gas (GHG) emissions since 2015, including the integration of Alexion’s GHG footprint.

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “We are making great progress on our ambition to be zero carbon across our global operations by the end of 2025 and carbon negative across our entire value chain by 2030.

Our collaboration with Honeywell demonstrates AstraZeneca’s commitment to advancing sustainable healthcare innovation, with the aim of improving outcomes for patients while reducing our environmental footprint.”

Darius Adamczyk, Chairman and Chief Executive Officer, Honeywell, said: “The work we are doing with AstraZeneca developing a respiratory inhaler, with a new near-zero Global Warming Potential propellant, is tremendously important for both the environment and patients with respiratory issues.

Our goal is to reduce respiratory healthcare carbon emissions without restricting patient choice or risking improvement in health outcomes.”

Next-generation respiratory inhalers
Most patients with asthma and chronic obstructive pulmonary disease (COPD) need inhaled medicines and many make use of pressurised metered dose inhalers (pMDIs) which contain small quantities of a type of GHG which acts as the propellant to deliver the medicine into the lungs.

Recent results from the first in-human Phase I trial of the near-zero GWP propellant HFO-1234ze in a pMDI containing budesonide, glycopyrronium, formoterol fumarate in healthy adults were positive, demonstrating similar safety, tolerability and systemic exposure of the active ingredients when compared to Breztri Aerosphere (budesonide/glycopyrronium/ formoterol fumarate).

AstraZeneca expects Breztri to be the first medicine to transition to this new pMDI platform, subject to regulatory approval.

In addition to offering next-generation pMDIs, AstraZeneca will continue offering dry powder inhaled medicines.

Respiratory diseases affect hundreds of millions of people around the world and there is a significant clinical need for pMDIs which are important device options for patients.

Familiarity with device, limited lung function, and young or advanced age are all important considerations when choosing the type of inhaler that best suits the patient.

Supply chain science-based climate targets
AstraZeneca is one of the first seven companies globally to have its net zero targets verified by the Science Based Targets initiative (SBTi) in line with their Corporate Net Zero  Standard. 

To support its decarbonisation goals, AstraZeneca aims for 95% of its key suppliers and partners to have science-based targets by the end of 2025.

The Company is committed to sharing lessons learned from its own decarbonisation pathway, and is a founding member of the Energize programme launched at COP26 which focuses on increasing access to renewable energy for pharmaceutical supply chains, as well as the Sustainable Markets Initiative (SMI) Health Systems Taskforce which aims to accelerate the delivery of net zero healthcare.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/astrazeneca-progresses-ambition-zero-carbon-programme-with-honeywell-partnership-to-develop-next-generation-respiratory-inhalers.html

FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States

admin
-
0
FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States

February 18, 2022: “The U.S. FDA is alerting the public that several categories of FDA-regulated products purchased from Jan. 1, 2021, through the present from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use.

The impacted products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection found insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated.

The FDA is working with the company to initiate a voluntary recall External Link Disclaimer of the affected products.

“Families rely on stores like Family Dollar for products such as food and medicine. They deserve products that are safe,” said Associate Commissioner for Regulatory Affairs Judith McMeekin, Pharm.D.

“No one should be subjected to products stored in the kind of unacceptable conditions that we found in this Family Dollar distribution facility.

These conditions appear to be violations of federal law that could put families’ health at risk. We will continue to work to protect consumers.”

This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. 1, 2021, through the present.

Some examples of these products include human foods (including dietary supplements (vitamin, herbal and mineral supplements)), cosmetics (skincare products, baby oils, lipsticks, shampoos, baby wipes), animal foods (kibble, pet treats, wild bird seed), medical devices (feminine hygiene products, surgical masks, contact lens cleaning solutions, bandages, nasal care products) and over-the-counter (OTC) medications (pain medications, eye drops, dental products, antacids, other medications for both adults and children). 

Consumers are advised not to use and to contact the company regarding impacted products. The agency is also advising that all drugs, medical devices, cosmetics and dietary supplements, regardless of packaging, be discarded.

Food in non-permeable packaging (such as undamaged glass or all-metal cans) may be suitable for use if thoroughly cleaned and sanitized.

Consumers should wash their hands immediately after handling any products from the affected Family Dollar stores.

Consumers who recently purchased affected products should contact a health care professional immediately if they have health concerns after using or handling impacted products. 

Rodent contamination may cause Salmonella and infectious diseases, which may pose the greatest risk to infants, children, pregnant women, the elderly and immunocompromised people.

Following a consumer complaint, the FDA began an investigation of the Family Dollar distribution facility in West Memphis, Arkansas, in January 2022.

Family Dollar ceased distribution of products within days of the FDA inspection team’s arrival on-site and the inspection concluded on Feb. 11.

Conditions observed during the inspection included live rodents, dead rodents in various states of decay, rodent feces and urine, evidence of gnawing, nesting and rodent odors throughout the facility, dead birds and bird droppings, and products stored in conditions that did not protect against contamination.

More than 1,100 dead rodents were recovered from the facility following a fumigation at the facility in January 2022.

Additionally, a review of the company’s internal records also indicated the collection of more than 2,300 rodents between Mar. 29 and Sep. 17, 2021, demonstrating a history of infestation.”

https://www.fda.gov/news-events/press-announcements/fda-alerts-public-potentially-contaminated-products-family-dollar-stores-six-states

Sanofi’s Update on ongoing Dupixent® chronic spontaneous urticaria Phase 3 program

admin
-
0
Sanofi’s Update on ongoing Dupixent® chronic spontaneous urticaria Phase 3 program

February 18 2022: “A Phase 3 trial (CUPID STUDY B) evaluating Dupixent® (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis.

Although positive numerical trends in reducing itch and hives were observed, the results from the interim analysis did not demonstrate statistical significance for the primary endpoints.

The analysis was conducted by an independent interim analysis review committee.

In the trial, patients who were refractory to omalizumab treatment and uncontrolled on antihistamines received Dupixent plus standard of care compared to standard of care alone for 24 weeks.

The safety data were generally consistent with the known safety profile of Dupixent in its approved indications.

The LIBERTY-CUPID pivotal program was initiated in 2020 with an accelerated direct-to-Phase 3 strategy.

The previously reported Phase 3 trial, which evaluated a different group of patients who were biologic-naïve, met its primary and all key secondary endpoints at 24 weeks showing that adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives compared to antihistamines alone.

The companies remain committed to advancing Dupixent for patients with CSU uncontrolled on antihistamines and are evaluating next steps.

John Reed, M.D., Ph.D.
Executive Vice President, Global Head of Research and Development at Sanofi
“Although we are disappointed in these latest results, this interim analysis contributes to furthering our understanding of the role of type 2 inflammation in this subset of CSU patients who are refractory to all other approved therapies. 

Based on the results seen in our first Phase 3 trial, and the numerical trends observed in this interim analysis, we remain committed to advancing Dupixent as an option for patients suffering from CSU who are uncontrolled on anti-histamines. We look forward to discussing next steps with regulators.”

Detailed results from the first trial will be presented at the AAAAI Annual Meeting later this month and the companies expect to share results from the second trial in a scientific forum.

Sanofi and Regeneron are rapidly advancing a broad clinical development program to evaluate Dupixent in diseases with significant unmet need and where type 2 inflammation may play a role.

The companies also recently announced positive Phase 3 results in eosinophilic esophagitis (EoE) and prurigo nodularis (PN), and additional results are also expected later this year in pediatric EoE, chronic inducible urticaria-cold (CindU), and hand and foot atopic dermatitis.

The potential use of Dupixent in CSU, EoE, PN, CindU and hand and foot atopic dermatitis are currently under clinical development and the safety and efficacy have not been fully evaluated by any regulatory authority.

About Chronic Spontaneous Urticaria

CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin.

Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itch or burning sensation, which can be debilitating and significantly impact quality of life.

Swelling often occurs on the face, hands and feet, but can also affect the throat and upper airways.

About the Dupixent Phase 3 Program in CSU (LIBERTY-CUPID)

Study B of the Phase 3 randomized, double-blind, placebo-controlled LIBERTY-CUPID clinical program evaluated the efficacy and safety of Dupixent in 83 patients with CSU aged 12 to 80 years who remained symptomatic despite standard-of-care treatment and were intolerant or incomplete responders to omalizumab.

During the 24-week treatment period, patients received Dupixent, or placebo every two weeks added to standard-of-care antihistamines.

The primary endpoints assessed the change from baseline in itch (measured by the weekly itch severity score) and the change from baseline in itch and hives (measured by the weekly urticaria activity score) at 24 weeks.

Study A of clinical program evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone in 138 patients aged 6 years and older with CSU who remained symptomatic despite antihistamine use and were not previously treated with omalizumab.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-02-18-07-00-00-2387700

1...262728...157Page 27 of 157

EDITOR PICKS

POPULAR POSTS

POPULAR CATEGORY

ABOUT US

LifeProNow provides guidance and high quality contents to help job seekers to get their dream Job. All the contents are written by experienced folks and peer reviewed by experts.

Contact us: [email protected]

FOLLOW US

© LifeProNow | All Rights Reserved