Benzinga | Nov 12, 2021 10:26AM EST

Regeneron Pharmaceuticals' Co-Developed Antibody Cocktail Approved By European Commission To Treat And Prevent COVID-19

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has approved the casirivimab and imdevimab antibody cocktail, known as REGEN-COV(r) in the U.S. and Ronapreve(tm) in the European Union (EU) and other countries. The EC granted marketing authorization for the antibody cocktail for people aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent COVID-19. This decision follows yesterday's positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

"This approval adds to the growing number of countries that have recognized our antibody cocktail as an important therapy against COVID-19 to treat non-hospitalized patients already infected with the virus and to prevent infection in the first place," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "With today's approval, we hope countries in the European Union will accelerate their adoption of this formidable tool to reduce the burden of COVID-19. For non-hospitalized infected individuals, our antibody cocktail was shown to reduce the risk of hospitalization or death by 70%; and in the prevention setting it reduced the risk of symptomatic infections by 82%. Further, recently released data not yet reviewed by the EMA suggest a single dose provided long-term protection against COVID-19, beyond the currently authorized once-monthly dosing; we will share these new data with regulatory authorities, including the EMA, to better meet the needs of these patients."

The EC approval is based on two positive Phase 3 trials involving more than 6,000 individuals that evaluated the efficacy and safety of the antibody cocktail to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals (both uninfected and infected contacts).

Regeneron invented the antibody cocktail and is collaborating with Roche, who is primarily responsible for development and distribution outside the U.S. In addition to this Marketing Authorization Application, the companies intend to submit a future Type II Variation to the EMA that seeks to expand the indication to include the treatment of patients hospitalized because of COVID-19.

In October, the U.S. Food and Drug Administration (FDA) accepted for priority review the first of two Biologics License Applications (BLAs) for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The second BLA submission will focus on those hospitalized because of COVID-19 and is expected to be completed later this year.

Emergency or temporary pandemic use authorizations are currently in place in more than 40 countries, including the U.S., India, Switzerland and Canada, andthe antibody cocktailisfully approved in Japan and conditionally approved in the United Kingdom and Australia. In the U.S., REGEN-COV has not been approved by the FDA, but is currently authorized under an Emergency Use Authorization (EUA) for use in certainpost-exposure prophylaxissettings and as a treatment for people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19.

Regeneron and Roche share a commitment to making the antibody cocktail available 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.

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.