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.
George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron stated, "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."
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.
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