Merck, Ridgeback to seek EUA for oral COVID antiviral

Oct. 1, 2021

Merck (MSD) and Ridgeback Biotherapeutics announced their investigational oral antiviral medicine, molnupiravir, significantly reduced the risk of hospitalization or death from COVID.

A planned interim analysis of the phase 3 MOVe-OUT trial in at-risk, non-hospitalized adult patients with mild-to-moderate COVID found that molnupiravir reduced the risk of hospitalization or death by approximately 50%. Specifically, 7.3% of patients who received molnupiravir were either hospitalized or died through day 29, compared with 14.1% of placebo-treated patients. Through day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.

Due to the positive results — at the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. FDA — the partners plan to halt study recruitment. Merck says it plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on the findings and plans to submit marketing applications to other regulatory bodies worldwide.

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