Merck submits EUA request for oral antiviral molnupiravir as COVID-19 treatment
Merck and Ridgeback Biotherapeutics have announced that they submitted an emergency use authorization application to the FDA for molnupiravir, an oral antiviral that “inhibits the replication of SARS-CoV-2.”
The treatment is being studied in adults with mild-to-moderate COVID-19 who are at risk for progressing to severe disease or hospitalization, according to a press release from Merck. If authorized, it could be the first oral antiviral for the treatment of COVID-19, the release said.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency,” Robert M. Davis, CEO and president of Merck, said in the press release.
Phase 3 trial data released by Merck earlier this month indicated that patients who received molnupiravir were about 50% less likely to be hospitalized or die from COVID-19 compared with patients who received placebo. The trial also showed that molnupiravir appeared to demonstrate “consistent efficacy” against SARS-CoV-2 variants.
According to the release, Merck has already started manufacturing molnupiravir and expects to have 10 million treatment courses produced by the end of the year. The company has also entered into agreements with governments around the world, including the United States, to ensure “timely access” of the therapy upon regulatory authorization, the release said.
“We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible,” Davis said.