Regeneron requests FDA approval for antibody cocktail to be used as preventive

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Regeneron said April 12 it is requesting the FDA approve its COVID-19 antibody cocktail as a preventive treatment after data from a phase 3 trial showed the drug reduced the risk of symptomatic COVID-19 infection by 81 percent.

The trial enrolled 1,505 uninfected participants who lived in the same household as someone who tested positive for COVID-19 within the prior four days. Half of them received one 1,200 milligram dose of the antibody cocktail, and half received a placebo.

The FDA granted emergency use authorization Nov. 21 to Regenron's COVID-19 antibody treatment, a combination of casirivimab and imdevimab, to treat adults with mild-to-moderate COVID-19 and pediatric patients at least 12 years old who have COVID-19 and are at high risk of severe disease. 

Regeneron's president and chief scientific officer, George Yancopoulos, MD, PhD, said the drugmaker is asking that the emergency use authorization be expanded because the antibody cocktail could help provide immediate protection to unvaccinated people who are exposed to the virus. He also said the drugmaker is working to understand the drug's potential to provide protection to immunocompromised patients who may not respond well to vaccines.

More articles on pharmacy:
COVID-19 vaccine supply could outweigh demand by end of April
4 cases of blood-clotting after J&J COVID-19 shots probed by EU drug agency
How 4 pharmacy chains, vaccine sites are preventing wasted doses

 

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