Merck & Ridgeback Biotherapeutics disclosed updated results of its Covid-19 pill and it indicated that it reduced the risk of hospitalization or death among adults with mild to moderate disease by 30%, compared to 50 % in the earlier study.

Merck has sought US authorization for molnupiravir, also called Lagevrio, in October after a late-stage study showed it cut the risk of hospitalization or death by around 50% in high-risk patients.

Data are now available from all enrolled participants (n=1433). 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 U.S. Food and Drug Administration (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 favourable 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 Nov. 30^th.