Merck now says molnupiravir reduces the risk of hospitalization or death from COVID-19 by 30% after all data have been analyzed. Previously, an interim analysis showed a 50% reduction in hospitalization or death.
An analysis of all enrolled patients in the study of molnupiravir showed that the antiviral to treat COVID-19 reduced the risk of hospitalization or death from 9.7% in the placebo group to 6.8% in the molnupiravir group, for a relative risk reduction of 30%. Nine deaths were reported in the placebo group, and one in the molnupiravir group in the phase 3 MOVe-OUT clinical trial, which enrolled 1,433 participants. The adverse event profile for molnupiravir remained consistent with the profile reported at the planned interim analysis.
In October 2021, however, developers Merck and Ridgeback Biotherapeutics provided an interim analysis of 762 patients. Researchers found that 7.3% of patients who received molnupiravir were either hospitalized or died through day 29 following randomization, compared with 14.1% of placebo-treated patients. Through day 29, no deaths were reported in patients who received molnupiravir, compared with eight deaths in patients who received the placebo.
Merck officials said in a statement that 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 the FDA.
Merck has shared these additional analyses with the FDA, and the data will be presented to the FDA’s Antimicrobial Drugs Advisory Committee on Nov. 30, 2021.
Molnupiravir has been authorized for use in the U.K. The FDA is reviewing Merck’s application for emergency use authorization. The European Medicines Agency is reviewing Merck’s application for marketing authorization.
Molnupiravir was invented at Emory University and licensed to Ridgeback Biotherapeutics by Drug Innovation Ventures at Emory. It is being develop by Merck in collaboration with Ridgeback.