Merck Inc., and Ridgeback Biotherapeutics provide update on results from the MOVe-OUT study of molnupiravir, an oral antiviral in at risk adults with mild-to-moderate COVID-19.
In this study population, molnupiravir reduced the risk of hospitalization or death from 9.7% in the placebo group (68/699) to 6.8% (48/709) in the molnupiravir group, for an absolute risk reduction of 3.0% (95% confidence interval [CI]: 0.1, 5.9; nominal p-value=0.0218) and a relative risk reduction of 30% (relative risk 0.70; 95% CI: 0.49, 0.99). Nine deaths were reported in the placebo group, and one in the molnupiravir group.The adverse event profile for molnupiravir remained consistent with the profile reported at the planned interim analysis.
Based on the study design, the definitive evaluation of efficacy was considered complete at the planned interim analysis, when the statistical criterion for success was met and enrollment in the study was discontinued at the recommendation of the external Data Monitoring Committee and agreed to by the FDA. As previously reported, at the planned interim analysis, molnupiravir significantly reduced the risk of hospitalization or death from 14.1% (53/377) in the placebo group to 7.3% (28/385) in the molnupiravir group (absolute risk reduction 6.8%; 95% CI: 2.4, 11.3; p=0.0012), for a relative risk reduction of 48% (relative risk 0.52; 95% CI: 0.33, 0.80).
The interim analysis and the additional analyses support the efficacy and overall favorable benefit-risk assessment of molnupiravir for the treatment of mild to moderate COVID-19 in adults at high risk for disease progression. Merck has shared these additional analyses with the FDA and they will be presented to the FDA’s Antimicrobial Drugs Advisory Committee on 30 November 2021.
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