Merck Submits Emergency Use Authorization Application to FDA for Oral Antiviral Molnupiravir Against COVID-19

On October 11, MSD announced that it has submitted an Emergency Use Authorization (EUA) application to the FDA for the oral antiviral drug molnupiravir (MK-4482). If approved, molnupiravir will become the first oral antiviral drug for COVID-19.

Source: MSD Official Website

This EUA is based on the positive interim analysis results from the Phase 3 MOVe-OUT trial. The study evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19. In the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; by Day 29 after randomization, 7.3% of patients receiving molnupiravir were hospitalized or died (28/385), compared with 14.1% in the placebo group (53/377), p = 0.0012. Through Day 29, no deaths were reported among patients treated with molnupiravir, whereas 8 deaths occurred in the placebo group.

In terms of safety, the incidence of any adverse events was comparable between the molnupiravir group and the placebo group (35% and 40%, respectively), and the incidence of drug-related adverse events was also comparable (12% and 11%, respectively).

Earlier this year, MSD reached a procurement agreement with the U.S. government. Under the agreement, the company will supply approximately 1.7 million doses of molnupiravir to the U.S. government upon receiving an Emergency Use Authorization (EUA) or regulatory approval. Additionally, MSD has signed supply and advance purchase agreements for molnupiravir with governments of other countries worldwide.