Regeneron Pharmaceuticals, Inc. today announced that the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted Conditional Marketing Authorization (CMA) for the casirivimab and imdevimab antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in the UK and other countries, to prevent and treat acute COVID-19 infection. In addition to the CMA, which affects people in England, Scotland and Wales, the MHRA has also authorized emergency supply of the antibody cocktail to prevent and treat acute COVID-19 infection for people in Northern Ireland.
"Despite the remarkable collective efforts of governments, healthcare professionals and communities across the globe, COVID-19 continues to cause significant illness and death, with new variants making the fight even more challenging," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "In addition to preventing hospitalization and death in patients already infected with the virus, we are encouraged that governments recognize the benefits of REGEN-COV in preventing infection in the first place, including in immunocompromised people who may not respond to vaccines due to an underlying medical condition, or medicines used to treat an underlying condition. This indication is now authorized in the UK and available under early access authorization in France, and we are in ongoing discussions with other regulatory authorities, including the U.S. FDA, to help bring REGEN-COV prevention to the many at-risk immunocompromised individuals who are not sufficiently protected by vaccination."
As part of the MHRA decisions announced today, the antibody cocktail is authorized to treat people across the UK who have an existing infection or to prevent COVID-19 infection, including among people who may need ongoing monthly doses if they have a medical condition making them unlikely to respond to or be protected by vaccination. The MHRA authorizations are based on results from two Phase 3 trials evaluating the antibody cocktail to treat high-risk non-hospitalized patients and prevent symptomatic infection in asymptomatic household contacts (both uninfected and infected) of SARS-CoV-2 infected individuals.
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The CMA scheme, which covers England, Scotland and Wales, is for products that fulfill an unmet medical need, for example where no satisfactory treatments are available or where the product offers a major therapeutic advantage, and are valid for one year (renewable annually). For people in Northern Ireland, the MHRA emergency supply authorization of the antibody cocktail occurred under regulation 174 of the Human Medicines Regulations 2012, and is valid until expressly withdrawn by the MHRA.
Emergency or temporary pandemic use authorizations are currently in place in more than 20 countries, including in the U.S., in several European Union countries, India, Switzerland and Canada, and the antibody cocktail is fully approved in Japan. Regeneron invented the antibody cocktail and is collaborating with Roche to increase global supply, with Roche primarily responsible for development and distribution outside the U.S., including throughout the UK.
In the U.S., REGEN-COV is available for free to eligible people, as part of a U.S. government funded program. REGEN-COV use is increasing across the U.S. following the latest
COVID-19 surge, with recent weekly orders surpassing 130,000 doses. In addition to the increasing proportion of patients who now receive REGEN-COV, Regeneron continues to work to ensure all healthcare providers and people who may benefit from this important therapy are aware of its availability.
Earlier this month Regeneron submitted the first of two Biologics License Applications (BLAs) for REGEN-COV. The initial submission included data on the efficacy and safety of
REGEN-COV to treat and prevent SARS-CoV-2 infection in non-hospitalized people. The second BLA submission will focus on those hospitalized because of COVID-19, and is expected to be completed later this year.
Multiple analyses, including a recent publication in Cell, have shown that the antibody cocktail retains potency against the main variants of concern circulating within the U.S. and other countries such as the U.K., including Delta (B.1.617.2; first identified in India), Gamma (P.1; first identified in Brazil) and Beta (B.1.351; first identified in South Africa). Consequently, REGEN-COV remains available for use across the U.S., and Regeneron will continue actively monitoring the potency of REGEN-COV against emerging variants.
The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.
About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune and VelociSuite technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Cell and Science.
The robust REGEN-COV development program has reported positive Phase 3 trial results across the spectrum of COVID-19 infection, from prevention to hospitalization:
REGEN-COV is available throughout the U.S. – information on availability in your area is available from the Department of Health and Human Services and the National Infusion Center Association. In the U.S., REGEN-COV is currently authorized to treat people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings. Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19 or for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. REGEN-COV has not been approved by the Food and Drug Administration (FDA), but is currently authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency uses under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Additional information about REGEN-COV in the U.S. is below (authorized uses and important safety information).
Regeneron and Roche share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.
About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN-COV (casirivimab and imdevimab), Dupixent (dupilumab), Libtayo (cemiplimab-rwlc), Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb) and Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn).
U.S. AUTHORIZED USES AND IMPORTANT SAFETY INFORMATION
REGEN-COV is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death
Limitations of Authorized Use (Treatment)
REGEN-COV is authorized in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
Limitations of Authorized Use (Post-Exposure Prophylaxis)
REGEN-COV has not been approved, but has been authorized for emergency use by FDA
These uses are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized uses of REGEN-COV and mandatory requirements of the EUA and must comply with the requirements of the EUA. The FDA Letter of Authorization is available for reference, as well as the Dear Healthcare Provider Letter and Patient Fact Sheet
Criteria for Identifying High Risk Individuals
Please refer to the Fact Sheet for Healthcare Providers for criteria for identifying high risk individuals
SARS-CoV-2 Viral Variants
Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Healthcare providers should review the Antiviral Resistance information in Section 15 of the Fact Sheet for details regarding specific variants and resistance, and refer to the CDC website as well as information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions
Important Safety Information
REGEN-COV (casirivimab and imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use
REGEN-COV is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to REGEN-COV
Warnings and Precautions:
Use in Specific Populations:
Date: Aug 20, 2021
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