Merck (known as MSD outside the United States and Canada), and Ridgeback Biotherapeutics have provided the following statement at the conclusion of the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) regarding the Emergency Use Authorization (EUA) application for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, for the treatment of mild to moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19 and/or hospitalization.
The Advisory Committee voted 13-10 that the known and potential benefits of molnupiravir outweigh its known and potential risks for the treatment of mild to moderate COVID-19 in high-risk adult patients who are within five days of symptom onset. The FDA is not bound by the committee’s guidance but takes its advice into account.
Merck’s submission to the FDA for EUA, as discussed by the AMDAC, is based on the positive results from a planned interim analysis of the Phase 3 MOVe-OUT clinical trial and the recent study update, including data from all randomized patients. MOVe-OUT evaluated molnupiravir in non-hospitalized adult patients with mild to moderate COVID-19 with symptom onset within five days prior to randomization who were at high risk for progressing to severe COVID-19 and/or hospitalization.
At the planned interim analysis, which based on the study design was the primary efficacy analysis of the study, treatment with molnupiravir significantly reduced hospitalizations and death through Day 29 following randomization: 14.1% of patients in the placebo group were hospitalized or died, compared to 7.3% of patients who received molnupiravir who were hospitalized; at the interim analysis, no patients who took molnupiravir died, compared to eight patients who received placebo.
The efficacy benefit with molnupiravir treatment was consistent across important patient subgroups, including patients infected with SARS-CoV-2 variants of concern, Delta, Gamma and Mu.