Merck submits emergency use application to FDA for oral COVID-19 treatment
(CBS 58) -- Merck has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral medicine that treats mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
Today, we submitted an Emergency Use Authorization application to the U.S. FDA for our investigational #COVID19#antiviral treatment. Read about today’s milestone: https://t.co/BHPzfkSw4K$MRKpic.twitter.com/y5WdTQnyHL— Merck (@Merck) October 11, 2021
Merck, known as MSD outside the United States and Canada, is actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months.
The submission is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalization.
At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50 percent.
It has to be taken within the first five days of symptoms.
Early results show the drug did not benefit people who were already hospitalized with COVID-19.
Doctors say it is not an alternative to getting vaccinated.