Merck Submits EUA Application for Oral Antiviral Molnupiravir Based on Phase 3 MOVE-OUT Trial Data

On the evening of November 30, it was reported that the FDA Drug Advisory Committee narrowly recommended the approval of Merck Sharp & Dohme AG's Molnupiravir for emergency use authorization by a vote of 13 to 10.

Previously (October 11), MSD announced that it had submitted an Emergency Use Authorization (EUA) application to the FDA for its oral antiviral drug Molnupiravir (MK-4482). Molnupiravir, developed by MSD in collaboration with Ridgeback Biotherapeutics, is an investigational ribonucleoside analog in an orally bioavailable form that inhibits the replication of SARS-CoV-2.

Notably, this EUA is based on the positive interim analysis results of the Phase 3 clinical MOVe-OUT study. The trial evaluated Molnupiravir in non-hospitalized adult patients with mild to moderate COVID-19.

In the interim analysis,Molnupiravir reduces the risk of hospitalization or death by approximately 50%.; On day 29 after randomization, 7.3% of patients who received Molnupiravir were hospitalized or died (28/385), compared to 14.1% (53/377) in the placebo group, p=0.0012. By day 29, no deaths were reported among patients who received Molnupiravir, while there were 8 deaths in the placebo group. In terms of safety, the incidence of any adverse events was similar between the Molnupiravir and placebo groups (35% vs. 40%, respectively), and the incidence of drug-related adverse events was also comparable (12% vs. 11%, respectively).

However, on November 26, MSD and Ridgeback announced updated clinical data for the COVID-19 oral drug Molnupiravir in treating mild to moderate COVID-19. Based on the data from all enrolled patients,Reduce hospitalization or mortality rate by 30%. There were 9 deaths in the placebo group and 1 death in the treatment group.