Merck & Co (MSD) and Ridgeback Biotherapeutics shared updated data from the study of its experimental COVID-19 antiviral, showing the drug was significantly less effective in cutting hospitalizations and deaths than previously reported.
Data from all 1,433 enrolled participants in the MOVe-OUT study of molnupiravir showed a 30% reduction in hospitalizations and deaths.
Merck's Emergency Use Authorization application, submitted to the U.S. FDA in October, was based on positive results from a planned interim analysis from the MOVe-OUT trial, which found that molnupiravir reduced the risk of hospitalization or death by 48% in at-risk, non-hospitalized adult patients with mild-to-moderate COVID.
Earlier in November, rival Pfizer reported that its interim analysis of its phase 2/3 antiviral study found its oral antiviral pill for COVID-19 cut rates of hospitalization and death by 89% in high-risk adults. The drugmaker submitted its application for the FDA to grant emergency authorization for the pill last week, and shortly after announced a $5.29 billion deal to supply 10 million courses of the treatment the U.S. government, contingent on the pill's authorization.
Earlier this year, Merck entered into a procurement agreement with the U.S. government under which the company will supply approximately 1.7 million courses of molnupiravir to the government upon EUA or approval from the U.S. FDA. Additionally, Merck has entered into supply and advance purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization.
Merck said it shared its updated analyses with the FDA and the will be presented to the FDA’s Antimicrobial Drugs Advisory Committee on Nov. 30th.