Merck and Ridgeback Biotherapeutics have announced their submission of an EUA application to the FDA for an oral antiviral medication for the treatment of COVID-19.
Merck and Ridgeback Biotherapeutics have announced their submission of an Emergency Use Authorization (EUA) application to the US Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral medication for the treatment of COVID-19.
The companies submitted the EUA based on the positive results of a planned interim analysis of the Phase 3 MOVe-OUT trial (NCT04575597) of adults with mild to moderate COVID-19 who were not hospitalized, but were at risk for progression to severe disease and/or hospitalization. Results of the interim analysis indicated that molnupiravir therapy reduced hospitalization and death risk by approximately 50%: only 7.3% of those who received molnupiravir therapy were hospitalized or died compared with 14.1% of those in the placebo group.
No deaths were reported in patients in the molnupiravir treatment group.
Molnupiravir (MK-4483/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits replication of SARS-CoV_2.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Robert M. Davis, CEO and president of Merck, in a press release. “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.”
Merck has produced molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021. The company is committed to providing timely global access to the drug if authorized or approved, in conjunction with a tiered pricing approach.
1. Merck and Ridgeback announce submission of emergency use authorization application to the U.S. FDA for molnupiravir, an investigational oral antiviral medicine for the treatment of COVID-19. News Release. Merck. October 1, 2021. Accessed October 15, 2021.