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GSK announces FDA approval for Nucala for chronic rhinosinusitis with nasal polyps

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GSK announces FDA approval for Nucala for chronic rhinosinusitis with nasal polyps

July 29, 2021: “GlaxoSmithKline announced that the FDA has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

This new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

CRSwNP accounts for 2-4% of the US population, affecting more than 5 million people.

CRSwNP is one of a variety of diseases arising from inflammation in different tissues associated with elevated levels of a type of white blood cell called eosinophils.

It is often characterised by raised eosinophil levels, in which soft tissue growth, known as nasal polyps, develop in the sinuses and nasal cavity.

CRSwNP can cause chronic symptoms such as nasal obstruction, loss of smell, facial pressure and nasal discharge.

Mepolizumab is the first anti-IL-5 biologic to be approved for adult patients with CRSwNP in the US.

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK said: “More than 5 million people in the US suffer with chronic rhinosinusitis with nasal polyps and today’s approval provides these patients with the first anti-IL-5 treatment option and an alternative to surgery to help reduce symptoms of this disease.

GSK is committed to exploring the role of IL-5 inhibition in eosinophil-driven diseases to help address unmet needs of patients.”

Tonya Winders, CEO & President, Allergy and Asthma Network (AAN) and President of Global Allergy and Airways Patient Platform (GAAPP) commented: “Patients with chronic rhinosinusitis with nasal polyps experience unpleasant symptoms across a range of severities. 

As there have been limited treatment options, particularly for those patients with severe disease, they may rely on oral steroids and recurrent surgery to manage their condition. 

We welcome the news that mepolizumab will now offer appropriate patients and healthcare providers a novel treatment option and alternative to surgery.”

The approval of mepolizumab as a treatment for CRSwNP is based on data from the pivotal SYNAPSE study which explored the effect of mepolizumab vs. placebo in over 400 patients with CRSwNP.

Mepolizumab achieved significant improvement in reducing the size of nasal polyps and nasal obstruction. 

All patients in the study received standard care, had a history of previous surgery (approximately one in three had ≥3 surgeries) and were in need of further surgery due to severe symptoms and increased size of their polyps.

SYNAPSE showed that there was a 57% reduction in the proportion of patients who had surgery in the group treated with mepolizumab vs. placebo, HR=0.43 (95% CI 0.25, 0.76).

In addition, the proportion of patients requiring systemic corticosteroid use during the 52-week treatment period was lower in patients who received mepolizumab.

Mepolizumab is also approved for use in three other eosinophilic driven diseases, the first indication being for patients with severe eosinophilic asthma aged six years and older. Additionally, mepolizumab was the first biologic therapy indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA) and also the first biologic to be approved for patients aged 12 years and older with hypereosinophilic syndrome (HES).

With 41 clinical trials, mepolizumab has been studied in over 4,000 patients. GSK is committed to improving the lives of those living with disease associated with uncontrolled eosinophilic inflammation, continuously innovating in order to address the unmet needs in this broad patient group.

Nucala is indicated in the US:

  • As an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. Nucala is not indicated for the relief of acute bronchospasm or status asthmaticus.
  • For the treatment of adult patients with EGPA.
  • For the treatment of adult and paediatric patients aged 12 years and older with HES for ≥6 months without an identifiable non-hematologic secondary cause.
  • As an add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

About chronic rhinosinusitis with nasal polyps (CRSwNP)

CRSwNP is a chronic inflammatory disease of the nasal passage linings or sinuses which can lead to soft tissue growths known as nasal polyps and is often characterised by elevated levels of eosinophils. The resultant swellings can grow in both nostrils (bilateral) greatly impacting a patient due to various symptoms including nasal obstruction, loss of smell, facial pressure and nasal discharge. Surgery may be indicated for severe cases. However, polyps have a strong tendency to reoccur often leading to repeat surgery. 

About mepolizumab

First approved in 2015 for severe eosinophilic asthma (SEA), mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels.

A normal level of blood eosinophils being less than 500 eosinophils/microliter. The mechanism of action for mepolizumab has not been definitively established.

Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils.

It has been studied in over 4,000 patients in 41 clinical trials across a number of eosinophilic indications and has been approved under the brand name Nucala in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with SEA.

It is approved for paediatric use in SEA from ages six to 17 in Europe, the US and several other markets.

In the US, Japan, Canada and a number of other markets, it is approved for use in adult patients with EGPA. Mepolizumab was approved for use in HES in the US in September 2020, followed by Brazil in February 2021 and Argentina in May 2021.

Mepolizumab is currently being investigated in COPD. It is not currently approved for use in COPD anywhere in the world.”

https://www.gsk.com/en-gb/media/press-releases/gsk-announces-fda-approval-for-nucala-mepolizumab-for-use-in-adults-with-chronic-rhinosinusitis-with-nasal-polyps/

Ipsen delivers strong H1 2021 results and upgrades full-year guidance

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Ipsen delivers strong H1 2021 results and upgrades full-year guidance

July 2021: Ipsen, a global specialty-driven biopharmaceutical company, today announced its financial results for the first half of 2021:

Strong financial results

  • Total sales growth in H1 2021 of 11.0% at CER1, or 6.5% as reported, to €1,350.3m
    • Q2 2021 total sales growth of 16.8% at CER1, or 12.7% as reported, to €691.8m
  • Core operating income of €479.8m (H1 2020: €410.2m); IFRS operating income of €412.2m (H1 2020: €249.8m)
  • Core operating margin2: 35.5% (H1 2020: 32.3%). IFRS operating margin: 30.5% (H1 2020: 19.7%)
  • Healthy balance sheet: net debt down to €336.5m, a reduction of €188.7m versus December 2020

Delivering against the strategy

  • Maximizing the brands:
    • Speciality Care sales growth in H1 2021 of 11.2%1 to €1,244.5m
    • Consumer Healthcare sales growth in H1 2021 of 8.6%1 to €105.9m
  • Strengthening the pipeline:
    • Good progress in external innovation: agreements announced in early and mid-stage pipeline
    • Regulatory submission acceptance for palovarotene in FOP in the U.S. and E.U.
    • Regulatory approval and launch of first-line renal cell carcinoma indication for Cabometyx® (cabozantinib) in combination with nivolumab and positive Phase III results for Cabometyx® in differentiated thyroid cancer
  • Driving efficiencies:
    • Cost savings driven by reduced face-to-face activity as a result of the pandemic, and by some efficiency gains
    • Ratio of SG&A expenses to total sales declined to 35.8% (H1 2020: 37.0%)
  • Focus on culture:
    • Strong momentum with Ipsen’s ambitious CSR4 agenda

Full-year guidance upgraded

  • Total sales growth: greater than +8.0% (prior guidance: greater than +4.0%)
  • Core operating margin: around 32.0% (prior guidance: greater than 30.0%)

David Loew, Chief Executive Officer, commented:

“Our strong results reflected the progress we are making with our new strategy. We continued to grow our brands, with particularly strong sales in the second quarter partly a result of the gradual lifting of pandemic confinement measures.

We achieved the important regulatory approval and launch of the combination of Cabometyx® with nivolumab in first-line renal cell carcinoma and, while we were disappointed with the recent Phase III data readout in liver cancer, our pipeline continued to strengthen, with the positive Phase III results for Cabometyx® in thyroid cancer and the regulatory submission of palovarotene in FOP.

This progress was coupled with recent licensing agreements in the early and mid-stage pipeline.

I was also pleased with the efficiencies achieved throughout our business, with the focus on our culture also underpinning more exciting opportunities to benefit patients and society.

Our raised expectations for our full-year results reflect the strength of our business. In the near term, we await further regulatory steps for palovarotene in the U.S. and Europe, while we continue to anticipate launches of generic lanreotide in Europe this year.

I expect Ipsen to continue to deliver, driven by a clear strategy, strong fundamentals and attractive growth opportunities, reinforced by an unrelenting focus on serving patients.”

https://www.ipsen.com/

FDA to Remove Unauthorized E-Cigarette Products from Market

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FDA to Remove Unauthorized E-Cigarette Products from Market

July 28, 2021: “The following quote is attributed to Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products

“The FDA issued a warning letter to a company with over 15 million tobacco products listed with the FDA, including many flavored e-liquids, for illegally marketing electronic nicotine delivery system (ENDS) products without authorization.

This action demonstrates the agency’s ongoing commitment toward ensuring that marketed tobacco products are in compliance with the law to better protect youth and the public health.

The warning letter is the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations.

The FDA wants all tobacco product manufacturers and retailers to know that we continue to watch the marketplace very closely and will hold companies accountable for breaking the law.

The FDA will continue to prioritize enforcement against companies that market ENDS without the required authorization and that haven’t submitted a premarket application to the agency – especially those products with a likelihood of youth use or initiation.”

Additional Information

  • The U.S. Food and Drug Administration issued awarning letter to Visible Vapors LLC—a company based in Pennsylvania that manufactures and operates a website selling electronic nicotine delivery system (ENDS) products, including e-cigarettes and e-liquids—advising them that marketing these new tobacco products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S.

    The firm did not submit any premarket tobacco product applications (PMTAs) by the Sept. 9, 2020, deadline.
  • Per court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-cigarettes and e-liquids—were required to be submitted to the FDA by Sept. 9, 2020.
  • While the warning letter issued today cites specific products as examples, including Visible Vapors Irish Potato 100mL and Visible Vapors Peanutbutter Banana Bacon Maple (The King) 100mL, the company has more than 15 million products listed with the FDA, and must ensure all of its products comply with federal rules and regulations, which include the premarket review requirement.
  • In line with the agency’s enforcement priorities, after Sept. 9, 2020, the FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a product application.
  • From January through June 2021, the FDA issued a total of 131 warning letters to firms selling or distributing more than 1,470,000 unauthorized ENDS and that did not submit premarket applications for such products by the Sept. 9 deadline.”

    https://www.fda.gov/news-events/press-announcements/fda-brief-fda-warns-firm-over-15-million-products-listed-fda-remove-unauthorized-e-cigarette

What is Interim Analysis in clinical trials?

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What is Interim Analysis in clinical trials?

INTRODUCTION

“Interim analysis is one of the reliable and consistent rational approaches to clinical trials that incorporates what is learned during the course of a clinical study and how it is completed without risking the validity or integrity of the study.

This method may include changes in all program-related resources and activities, such as logistical, monitoring, and recruitment procedures.

On a practical level, the study requires not only the ability to continuously measure the outcomes of interest, but also the ability to make data and summarised information about those measurements available in a timely manner to different audiences based on the study role.

In a clinical setting, this entails not only continuously tracking trial data collected on case report forms, but also generating performance metrics that allow for operational refinement.

Interest in this approach has grown as a result of the rising cost of clinical research and numerous trial failures, particularly costly and well-publicized failures of major late-stage trials.

The simplest outcome of such an interim analysis is either an early stop for futility or the continuation of the study.

This logical approach also enables clinical researchers to use the same basic management principles as typical modern businesses, such as using real-time data and analysis to inform decisions that continuously optimise operations.

INTERIM ANALYSIS AND STOPPING RULE

There are several practical and theoretical justifications for using this approach in clinical trials through a variety of group sequential designs that allow a limited number of planned analyses while maintaining a prespecified overall type I error rate and the study’s blind.

The interim analyses should be carried out by a body separate from the one in charge of the clinical trial’s day-to-day operations.

There are several prospective statistical strategies for early termination of a clinical trial.

Negative stopping is considered in flexible strategy and other statistical procedures such as stochastic limitation or conditional power approaches.

Actually, Stopping rules for interim analyses based on limited data require more stringent P values for stopping than stopping rules for later analyses, which can have stopping P values that are close to nominal levels of significance.

So, the key point of Interim Analysis can be:

The decision to conduct an interim analysis should be guided by clinical and statistical integrity, standard operating procedures for interim analyses, and regulatory concerns.

Such a decision should not be based on natural inclinations toward operational or academic curiosity.

As a result, unplanned interim analyses should be avoided because they have the potential to affect the data of a well-planned clinical trial.

A good set of performance metrics allows for a better understanding of the study’s progress, much tighter control, more effective resource allocation (such as monitoring time), faster enrollment, and, in the larger scheme of things, shorter timelines and lower costs in operations and decision-making.”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052936/https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.4780100613

https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.4780100613

https://www.sciencedirect.com/topics/medicine-and-dentistry/interim-analysis

FDA Approves First Interchangeable Biosimilar Insulin Product for Diabetes

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FDA Approves First Interchangeable Biosimilar Insulin Product for Diabetes

July 28, 2021: “The U.S. FDA approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.

Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog.

Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes.

Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock, M.D.

“Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

Biological products include medications for treating many serious illnesses and chronic health conditions, including diabetes.

A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product).

This means you can expect the same safety and effectiveness from the biosimilar as you would the reference product.

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber.

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state.

Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs.

Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.

More than 34 million people in the U.S. today have been diagnosed with diabetes, which is a chronic (long-lasting) health condition that affects how the body stores and uses sugars and other nutrients for energy.

Most food is broken down into sugar (also called glucose) and released into the bloodstream. When blood sugar levels increase, it signals the pancreas to release insulin, which acts like a key to allow blood sugar to enter the body’s cells for use as energy.

With diabetes, the body doesn’t make enough insulin to keep sugar levels regulated in the normal range.

“Access to affordable insulin is critical and long-acting insulin products, like insulin glargine, play an important role in the treatment of Types 1 and 2 diabetes mellitus,” said Peter Stein, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

“The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product.”

All biological products are approved only after they meet the FDA’s rigorous approval standards.

The approval of Semglee (insulin glargine-yfgn) as biosimilar to, and interchangeable with Lantus (insulin glargine), is based on evidence that showed the products are highly similar and that there are no clinically meaningful differences between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) in terms of safety, purity and potency (safety and effectiveness).

It also showed that Semglee (insulin glargine-yfgn) can be expected to produce the same clinical result as Lantus (insulin glargine) in any given patient and that the risks in terms of safety or diminished efficacy of switching between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) is not greater than the risk of using Lantus (insulin glargine) without such switching.

Semglee (insulin glargine-yfgn), offered in 10 mL vials and 3 mL prefilled pens, is administered subcutaneously once daily.

Dosing of Semglee (insulin glargine-yfgn), like Lantus, should be individualized based on the patient’s needs and should not be used during episodes of hypoglycemia (low blood sugar) or in patients with hypersensitivity to insulin glargine products.

Also, like Lantus, Semglee (insulin glargine-yfgn) is not recommended for treating diabetic ketoacidosis.

Semglee (insulin glargine-yfgn) may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions, hypokalemia (low potassium in blood) and heart failure.

The most common side effects associated with insulin glargine products other than hypoglycemia include edema (fluid retention), lipodystrophy (pitting at the injection site), weight gain and allergic reactions, such as injection site reactions, rash, redness, pain and severe itching.

The FDA released new materials for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.

The FDA granted approval of Semglee (insulin glargine-yfgn) to Mylan Pharmaceuticals Inc.”

https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes

Sanofi’s Dupixent® significantly improved itch and hives in chronic spontaneous urticaria

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Sanofi’s Dupixent® significantly improved itch and hives in chronic spontaneous urticaria

July 29 2021: “A pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU), an inflammatory skin disease, met its primary endpoints and all key secondary endpoints at 24 weeks.

Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naïve patients, compared to those treated with antihistamines alone (placebo) in Study A (the first of two trials) of the LIBERTY CUPID clinical program.

“The chronic nature of CSU, coupled with intense itch, causes both a physical and emotional burden on people who have not found an effective treatment,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. 

“This is the fifth inflammatory disease in which Dupixent has demonstrated a significant improvement in symptoms and disease manifestations in Phase 3 pivotal studies.

The success of this trial underscores the agility of our clinical operations team considering the pandemic conditions and underscores our ability to deliver on an aggressive timeline for addressing a significant unmet need for this patient population.”

“This is the first Phase 3 trial to show that by targeting IL-4 and IL-13, Dupixent can address the debilitating symptoms of chronic spontaneous urticaria like persistent itch and hives when standard-of-care antihistamines cannot sufficiently control the disease,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron.

“These data add to the increasing body of evidence that using Dupixent can reduce the disease burden of a diverse range of dermatologic, respiratory and gastrointestinal diseases.

By early 2022 we look forward to reporting results from a second trial in patients who were unable to control their chronic spontaneous urticaria with another biologic medicine, as well other trial results in additional dermatologic diseases.”

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.

CSU is typically treated with antihistamines but for up to 50% of people living with CSU their disease remains uncontrolled and available treatment options are few. CSU is the fifth inflammatory disease for which Dupixent has achieved positive Phase 3 data, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis (EoE, investigational).

In the trial (n=138), adding Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone at 24 weeks:

  • 63% reduction in itch severity with Dupixent vs 35% with standard-of-care (antihistamines) as measured by a 0-21-point itch severity scale (10.24-point reduction with Dupixent vs 6.01-point reduction with standard-of-care) (p<0.001), the primary endpoint in the US (secondary endpoint in the EU) with continuous improvement out to week 24.
  • 65% reduction in urticaria activity (itch and hives) severity with Dupixent vs 37% with standard-of-care, as measured by a 0-42-point urticaria activity scale, (20.53-point reduction with Dupixent vs 12.00-point reduction with standard-of-care) (p<0.001), the primary endpoint in the EU (secondary endpoint in the US) with continuous improvement out to week 24.

The trial demonstrated safety results similar to the known safety profile of Dupixent in its approved indications.

For the 24-week treatment period, the occurrence of treatment emergent adverse events were generally similar between the Dupixent and placebo groups (50% of Dupixent patients and 59% of placebo patients).

The most common adverse events were injection site reactions (11% Dupixent, 13% placebo).

The potential use of Dupixent in CSU and EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-07-29-07-00-00-2270858

Sanofi provides update on avalglucosidase alfa EU submission for patients with Pompe Disease

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Sanofi provides update on avalglucosidase alfa EU submission for patients with Pompe Disease

July 27 2021: “The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for avalglucosidase alfa, a long-term enzyme replacement therapy for the treatment of people with Pompe disease.

The CHMP positive opinion and recommended indication reflect the robust data from avalglucosidase alfa’s clinical development program.

While Sanofi is pleased with the CHMP’s recognition of the clinically meaningful improvements demonstrated in the avalglucosidase alfa development program, the CHMP considered that avalglucosidase alfa does not qualify as a New Active Substance (NAS).

As a result, Sanofi will be requesting a re-examination of the CHMP opinion in relation to the NAS conclusion.

The positive opinion is based on data from the Phase 3 COMET study, which found that avalglucosidase alfa showed clinically meaningful improvements in respiratory function and movement endurance measures in people with late-onset Pompe disease.

About avalglucosidase alfa
Avalglucosidase alfa is an enzyme replacement therapy designed to target the mannose-6-phosphate (M6P) receptor, the underlying disease mechanism in Pompe disease.

With approximately 15-fold increase in M6P content compared to the current standard of care, avalglucosidase alfa aims to help improve cellular enzyme uptake and enhance glycogen clearance in target tissues.

The CHMP positive opinion for avalglucosidase alfa follows the EMA’s acceptance of Sanofi’s MAA at the end of 2020.

Avalglucosidase alfa is also currently undergoing review in other countries including the U.S., U.K. and Japan.

The U.S. FDA has granted Breakthrough Therapy, Fast Track and Priority Review designations to avalglucosidase alfa and the target FDA action date under the Prescription Drug User Fee Act is anticipated to be August 18, 2021.

Avalglucosidase alfa has been granted Promising Innovative Medicine designation in the U.K.

The safety and efficacy of avalglucosidase alfa have not been fully evaluated by any regulatory authority worldwide.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-07-27-19-23-10-2269762

Coronavirus (COVID-19) Update: July 23, 2021

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Coronavirus (COVID-19) Update: July 23, 2021

July 23, 2021: “The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The agency updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA’s response efforts.
  • On Thursday, July 22 the FDA issued an Emergency Use Authorization (EUA) to Becton, Dickinson and Company (BD) for its BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), which are sodium citrate blood specimen collection tubes used to collect, transport, and store blood samples for coagulation testing.

    The device authorized under this EUA is for use in coagulation testing, performed by authorized laboratories, to aid in the identification and treatment of coagulopathy in patients, including patients with known or suspected COVID-19.

    The FDA also posted frequently asked questions (FAQs) about sodium citrate blood specimen collection tubes. For details on the EUA, see the letter of authorization.
  • A new FDA Voices, Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines, describes efforts being made to address inadequacies in research through a paradigm shift in the approach to studying medical products in pregnant and breastfeeding women.  
  • As part of the FDA’s effort to protect consumers, on Tuesday, July 20 the agency issued a warning letter to Jordan’s Crossing Herbal Connections for selling an unapproved product with unproven COVID-19 claims.

    Consumers concerned about COVID-19 should consult with their health care provider.
  • Testing updates: 
    • As of today, 395 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs).

      These include 279 molecular tests and sample collection devices, 86 antibody and other immune response tests and 30 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples.

      There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
    • The FDA has authorized 11 antigen tests and eight molecular tests for serial screening programs.
      The FDA has also authorized 586 revisions to EUA authorizations.”

      https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-23-2021

AZ’s Vaxzevria and mRNA COVID-19 vaccines showed similar safety profiles

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AZ’s Vaxzevria and mRNA COVID-19 vaccines showed similar safety profiles

July 28, 2021:Incidence of very rare thromboembolic events was far lower than in people diagnosed with COVID-19 infection
 

In a large real-world study, data published as a pre-print on The Lancet server from over one million individuals assessed the incidence rates of blood clotting disorders of thromboembolism and thrombocytopenia, including the very rare thrombosis with thrombocytopenia (TTS) following vaccination with an mRNA vaccine or Vaxzevria, and compared them with expected rates in a general population and in people with COVID-19.

Safety profiles of Vaxzevria, and the mRNA-based vaccine were similar and overall favourable.

Very rare clotting disorders (TTS) were observed with both vaccines but these were in line with what would be expected in the general population and lower than in those diagnosed with COVID-19.

Follow-up time was not sufficient to report rates after two doses of Vaxzevria, though other studies have shown rates of rare blood clotting events to be lower after a second dose.

Regardless of the vaccine used, the increase in rates of thrombosis among persons infected with COVID-19 was far higher than among those vaccinated.

Rates of venous thromboembolism were eight times higher after a diagnosis of COVID-19 infection compared with the expected rate.

Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “This real-world study offers further evidence of the favourable benefit:risk profile of Vaxzeria and demonstrates the critical role all COVID-19 vaccines are playing in combatting the pandemic.”

The analysis included 945,941 mRNA participants (778,534 with two doses), 426,272 Vaxzevria participants, conducted between 27 December 2020 and 19 May 2021.

It also included 222,710 COVID-19 participants identified between 1 September 2020 and 1 March 2021, and 4,570,149 background participants as of 1 January 2017 from a public health database held in Catalonia, Spain.

The results are in line with recent reports in the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Report, the UK system for collecting and monitoring information on safety concerns, which also show low rates of TTS after a second dose.

No specific risk factors or definitive cause for TTS following COVID-19 vaccination have been identified and AstraZeneca continues to perform and support ongoing investigations of potential mechanisms.

Furthermore, these very rare events can be managed when symptoms are identified and treated appropriately.

Vaxzevria, formerly AZD1222
Vaxzevria was co-invented by the University of Oxford and its spin-out company, Vaccitech.

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.

After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

The vaccine has been granted a conditional marketing authorisation or emergency use in more than 80 countries across six continents. 

More than 800 million doses of COVID-19 Vaccine AstraZeneca have been supplied to more than 170 countries worldwide, including more than 100 countries through the COVAX Facility.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/vaxzevria-and-mrna-covid-19-vaccines-showed-similar-and-favourable-safety-profiles-in-a-population-based-cohort-study-of-over-a-million-people.html

CanSinoBIO Announces Approval for Its Group A and Group C Meningococcal Conjugate Vaccine in China

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CanSinoBIO Announces Approval for Its Group A and Group C Meningococcal Conjugate Vaccine in China

June 23, 2021: “CanSino Biologics announced that the NMPA granted approval for its Group A and Group C Meningococcal Conjugate Vaccine (CRM197).

Menphecia provides protection against infection of Group A and C neisseria meningitidis.

CanSinoBIO significantly improved the product quality and safety profile by using CRM197 as a protein carrier and excluding animal-origin ingredients in culturing.

Based on the polysaccharide-protein conjugate technology, Menphecia overcomes the weaknesses of traditional Meningococcal Polysaccharide Vaccine (“MPV”), enhances the induced immune response and provides stronger immune protection.

According to the results of phase III clinical trial, comparing to the other granted MCV2 vaccines in China, Menphecia has a better safety profile in the 3 months old participant group, and better immunogenicity of Group A meningococcus in the 6 to 11 months old and 12 to 23 months old participant groups.

Meningococcal disease is a highly infectious disease caused by Neisseria meningitidis. Without timely treatment, the fatality rate can reach between 20% and 35% among infants below 12 months old.

Currently, vaccination is the most efficient way to prevent meningococcal disease. Today, every child below 6 years old needs to have the MCV vaccine, according to the national immunization program of China.

For children below 2 years old, Menphecia or other MCV2 vaccines could be a better option than traditional MPV vaccines.

The prevention of meningococcal disease through vaccination has been driving the significant growth of the Chinese meningococcal vaccine market.”

http://www.cansinotech.com/html/1///179/180/769.html

CHMP approves Moderna’s COVID-19 Vaccine in 12-17 old in EU

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CHMP approves Moderna’s COVID-19 Vaccine in 12-17 old in EU

Jul. 23, 2021: Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines Agency’s CHMP adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older. 

Spikevax is the trade name authorized by the European Medicines Agency (EMA) for the Moderna COVID-19 vaccine.

“The CHMP recommendation of the authorization of our COVID-19 vaccine for use in individuals 12 years of age and older in the European Union is a positive step forward toward authorization of our vaccine in this age group,” said Stéphane Bancel, Chief Executive Officer of Moderna.

“As we help to combat the pandemic, we hope to be able to help get adolescents safely back to school this fall.”

Following the CHMP’s positive opinion, the European Commission will consider authorizing the use of the Moderna COVID-19 Vaccine in adolescents ages 12 years of age and older.

On June 10, Moderna announced data from the ongoing Phase 2/3 study, which enrolled 3,732 participants ages 12 to less than 18 years in the U.S. The study met its primary endpoint, successfully bridging immune responses to those observed in the COVE efficacy study in adults. After two doses of the Moderna COVID-19 vaccine, no cases of COVID-19 were observed in the vaccine group using the case definition from the adult Phase 3 COVE study, compared to four cases in the placebo group, resulting in a vaccine efficacy of 100% starting 14 days after the second dose using the U.S. Centers for Disease Control and Prevention’s (CDC) primary definition of COVID-19 infection. The Moderna COVID-19 vaccine was generally well tolerated with a safety and tolerability profile consistent with the Phase 3 COVE study in adults. The majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia and chills.

Safety data continue to accrue, and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term efficacy and safety. The Company will revise the age range to capture adolescent data in its ongoing and planned post-authorization studies. 

Moderna has submitted data from the Phase 2/3 study to a peer-reviewed publication.

These data have also been submitted to health authorities around the world and the Company expects authorizations for adolescents in the coming weeks.

Moderna is also conducting a Phase 2/3 study, called the KidCOVE study, of mRNA-1273 in children ages 6 months to less than 12 years.”

https://investors.modernatx.com/news-releases/news-release-details/ema-committee-medicinal-products-human-use-chmp-adopts-positive

WHO reports progress in the fight against tobacco epidemic

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WHO reports progress in the fight against tobacco epidemic

July 27, 2021: Many countries are making progress in the fight against tobacco, but a new World Health Organization report shows some are not addressing emerging nicotine and tobacco products and failing to regulate them.

Increased adoption of WHO-recommended tobacco control measures

More than four times as many people are now covered by at least one WHO-recommended  tobacco control measure as compared with 2007.

The six MPOWER measures are monitoring tobacco use and preventive measures; protecting people from tobacco smoke; offering help to quit; warning about the dangers of tobacco; enforcing bans on advertising, promotion and sponsorship; and raising taxes on tobacco.

Some 5.3 billion people are now covered by at least one of these measures – more than four times the 1 billion who were covered in 2007.

More than half of all countries and half the world’s population are now covered by at least two MPOWER measures at the highest level of achievement.

This reflects an increase of 14 countries and almost one billion more people since the last report in 2019.

More than half of the world’s population are exposed to tobacco products with graphic health warnings. 

However, progress has not been even across all MPOWER measures. Some measures like raising tobacco taxes have been slow to move and 49 countries remain without any MPOWER measures adopted.

Need to tackle threats posed by new nicotine and tobacco products.

For the first time, the 2021 report presents new data on electronic nicotine delivery systems, such as ‘e-cigarettes’.

These products are often marketed to children and adolescents by the tobacco and related industries that manufacture them, using thousands of appealing flavours and misleading claims about the products..

WHO is concerned that children who use these products are up to three times more likely to use tobacco products in the future.  The Organization recommends governments to implement regulations to stop non-smokers from starting to use them, to prevent renormalization of smoking in the community, and to protect future generations..

“Nicotine is highly addictive. Electronic nicotine delivery systems are harmful, and must be better regulated,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, “Where they are not banned, governments should adopt appropriate policies to protect their populations from the harms of electronic nicotine delivery systems, and to prevent their uptake by children, adolescents and other vulnerable groups.”.

84 countries lack safe-guards to protect from unregulated proliferation of electronic nicotine delivery systems

Currently, 32 countries have banned the sale of electronic nicotine delivery systems (ENDS).

A further 79 have adopted at least one partial measure to prohibit the use of these products in public places, prohibit their advertising, promotion and sponsorship or require the display of health warnings on packaging.

This still leaves 84 countries where they are not regulated or restricted in any way.

Michael R. Bloomberg, WHO Global Ambassador for Noncommunicable Diseases and Injuries and founder of Bloomberg Philanthropies, said “More than 1 billion people around the world still smoke.

And as cigarette sales have fallen, tobacco companies have been aggressively marketing new products – like e-cigarettes and heated-tobacco products – and lobbied governments to limit their regulation.

Their goal is simple: to hook another generation on nicotine. We can’t let that happen.”

Dr Rüdiger Krech, Director of the Health Promotion Department at WHO, highlighted the challenges associated with their regulation.

“These products are hugely diverse and are evolving rapidly. Some are modifiable by the user so that nicotine concentration and risk levels are difficult to regulate.

Others are marketed as ‘nicotine-free’ but, when tested, are often found to contain the addictive ingredient.

Distinguishing the nicotine-containing products from the non-nicotine, or even from some tobacco-containing products, can be almost impossible.

This is just one way the industry subverts and undermines tobacco control measures.”

The proportion of people using tobacco has declined in most countries, but population growth means the total number of people smoking has remained stubbornly high.

Currently, of the estimated 1 billion smokers globally, around 80% of whom live in low- and middle-income countries (LMICs).

Tobacco is responsible for the death of 8 million people a year, including 1 million from second-hand smoke.

While ENDS should be regulated to maximize protection of public health, tobacco control must remain focused on reducing tobacco use globally.

MPOWER and other regulatory measures can be applied to ENDS.”

https://www.who.int/news/item/27-07-2021-who-reports-progress-in-the-fight-against-tobacco-epidemic

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