Regeneron Pharmaceuticals, Inc. 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.
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 Regeneron
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
