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COVID antiviral drug Molnupiravir efficacy against hospitalization or death drops to 30% compared to placebo group

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MSD and Ridgeback Biotherapeutics on Friday said its potential antiviral COVID-19 drug molnupiravir reduced the relative risk of hospitalization or death by 30% compared to placebo group.

The analysis of latest data on efficacy is much less than the previous interim analysis announced by the company which was based on data from 762 participants who were divided into molnupiravir group and the control group.

In the previous interim analysis the molnupiravir group relative risk reduction of death and hospitalisation compared to placebo group was 48%.

In an latest analysis based on the data from MOVe-OUT phase-3 clincal trials of molnupiravir (MK-4482, EIDD-2801), which has enroll 1433 participants, it was found the antiviral 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% and a relative risk reduction of 30%.

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.

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“In this study population, 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),” MSD said in its press release.

“The interim analysis and the additional analyses support the efficacy and overall favorable benefit-risk assessment of molnupiravir for the treatment of mild to moderate COVID-19 in adults at high risk for disease progression,” the statement said.

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Merck said it has shared these additional analyses with the FDA and they will be presented to the FDA’s Antimicrobial Drugs Advisory Committee on Nov 30.

Molnupiravir is being developed by Merck and Ridgeback for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-CoV-2 diagnostic test and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Molnupiravir has been authorized for use in the U.K.

The subject expert committee (SEC) of the Indian drug regulator is reviewing the applications of emergency use authorisation (EUA) of molnupiravir. The USFDA and the European Medicines Agency (EMA) are also reviewing the application for EUA.

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