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Regeneron asks FDA to Use Covid antibody therapy

Regeneron Pharmaceuticals plans to ask the Food and Drug Administration to allow its Covid-19 antibody therapy to be used as a preventative treatment. This therapy was given to former President Donald Trump shortly after he was diagnosed with Covid-19 last year, has already been authorized by the Food and Drug Administration to treat adults with mild-to-moderate Covid-19 and pediatric patients at least 12 years of age who have tested positive for the virus and are at high risk of severe disease.

Regeneron Pharmaceuticals is attempting to broaden the use of its treatment in the U.S. after a phase three clinical trial, jointly run by the National Institutes of Health, found the drug reduced the risk of symptomatic infections in individuals by 81%. The company also said that people who were symptomatic and were treated with the drug resolved their symptoms, on average, two weeks faster than those who received a placebo.

Dr. George Yancopoulos, president and chief scientific officer at Regeneron said that more than 60,000 Americans continue to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail may provide immediate protection to unvaccinated people who are exposed to the virus.

The trial included 1,505 people who were not infected with the virus but lived in the same household with someone who recently tested positive.  The Participants received either one dose of Regeneron therapy or a placebo.The company added that 41% of the people in the trial were Hispanic and 9% were Black. In addition, 33% of the participants were obese and 38% were age 50 and older. The therapy is part of treatments known as monoclonal antibodies, which are made to act as immune cells and fight infections.  Monoclonal antibody treatments had widespread attention after news that Trump received Regeneron drug.

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