Regeneron Pharmaceuticals (NASDAQ:REGN) is asking the U.S. Food and Drug Administration (FDA) to allow its COVID-19 antibody therapy to be used as a preventative treatment.
The therapy, which was given to former U.S. President Donald Trump after he was diagnosed with COVID-19 last fall, has already been authorized by the FDA to treat adults with mild-to-moderate COVID-19 and pediatric patients at least 12 years of age or older.
Regeneron said it is seeking to expand 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 COVID-19 infections in individuals by 81%.
The company also said people who were symptomatic and were treated with the drug resolved their symptoms, on average, two weeks faster than those who received a placebo. The trial enrolled 1,505 people who were not infected with the virus but lived in the same household with someone who recently tested positive.
Regeneron’s therapy is part of a class of treatments known as "monoclonal antibodies," which are made to act as immune cells and fight infections. Monoclonal antibody treatments gained widespread attention after then President Trump received Regeneron’s drug last October.
While the world’s attention has shifted to administering COVID-19 vaccines, health experts say treatments are also critically important to ending the global pandemic.
