According to updated data from the Move-Out study, the molnupiravir antiviral pill developed by Merck allows a reduction in the relative risk of hospitalization or death from Covid by 30%. An efficacy that is lower than that reported previously in the interim analysis of the same trial, which reported a halving of the risk (48% reduction). The two companies communicated the update, explaining that the data of all the participants enrolled in the trial (1,433 people) are now available. In this population, the drug reduced the risk of hospitalization or death from 9.7% calculated in the placebo group (68/699) to 6.8% (48/709) in the molnupiravir group, for an absolute reduction in the risk of 3.0% and a relative risk reduction of 30%. 9 deaths were reported in the placebo group, one in the molnupiravir group.
Based on the study design, the final efficacy assessment was considered complete at the planned interim review, when the statistical criterion for success was met and study enrollment was stopped on the recommendation of the External Monitoring Committee. data and after having agreed with the US FDA (Food and Drug Administration). Data from the interim analysis showed a reduction in the risk of hospitalization or death from 14.1% (53/377) in the placebo group to 7.3% (28/385) in the molnupiravir group, for an absolute risk reduction of 6.8% and a relative risk reduction of 48%.
“The interim analysis and additional analyzes support the efficacy and favorable overall benefit-risk assessment of molnupiravir for the treatment of mild to moderate Covid-19 in adults at high risk of disease progression,” it reads. in a note. These additional analyzes have been shared with the FDA and will be presented to the US agency’s specialized committee on November 30. Merck and Ridgeback Biotherapeutics, the note read, “have conducted a rigorous development program for molnupiravir and believe it has the potential to address a significant unmet medical need for an oral drug for adults with Covid at risk of progression to severe disease. and hospitalization We look forward to working with the FDA and other “regulatory agencies that” review our applications.