Regeneron Pharmaceuticals To Request FDA Clearance for Antibody Drug

On Monday, Regeneron Pharmaceuticals said that it would ask the Food and Drug Administration to allow its Covid-19 antibody therapy to be used as a preventative treatment. The therapy was given last year to former President Donald Trump shortly after he was diagnosed with Covid-19. It was granted authorization by the FDA to treat adults with mild-to-moderate Covid-19 patients and pediatric patients.

The treatment was approved for pediatric patients at least 12 years of age who have tested positive for the virus or are at high risk of severe disease. Regeneron Pharmaceuticals said that it was seeking to expand the use of the treatment in the US after a phase three clinical trial. The National Institutes of Health jointly run the test. It is found that the drug reduced the risk of symptomatic infections in individuals by 81%.

The company said people were symptomatic and were treated with the drug resolved their symptoms. Almost, it took more than those who received a placebo. Dr. George Yancopoulos, president and the chief scientific officer, said, “With more than 60,000 Americans continuing to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail may help provide immediate protection to unvaccinated people who are exposed to the virus.”

Nearly 1500 people who were not infected with the virus enrolled in the trial. The condition was that they lived in the same house with someone who recently tested positive. The participants either received a placebo or received one dose of Regeneron Pharmaceuticals’ therapy. The company said that 41% of the people were Hispanic, and 9% were black.