Merck Inc.,and Ridgeback statement on positive FDA Advisory Committee vote for investigational oral antiviral molnupiravir.
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 consideration.
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 III 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% (53/377) of patients in the placebo group were hospitalized or died, compared to 7.3% (28/385) 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 absolute risk reduction between the molnupiravir and the placebo arm was 6.8 percentage points (95% confidence interval [CI]: 2.4, 11.3; p=0.0012), which is approximately a 50% reduction in the risk of hospitalization or death through Day 29 compared with 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.
On 26 November, Merck Inc., announced additional analyses from all enrolled participants (n=1433). In this 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% 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. At the planned interim analysis, the incidence of any adverse event (AE) was comparable in the molnupiravir and placebo groups (35.0% and 39.6%, respectively)
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