FDA to review Merck and Ridgeback’s application in favor of oral antiviral medicine for COVID-19, Molnupiravir
Merck and Ridgeback Biotherapeutics, on Friday, provided an update on the MOVe-OUT study of Molnupiravir, an investigational oral antiviral medicine for COVID-19. The study was conducted with 1433 participants are now available.
The adverse event profile for molnupiravir remained consistent with the profile reported at the planned interim analysis. The interim and additional analyses support the efficacy of molnupiravir for the treatment of mild to moderate COVID-19 in people at high risk of disease development.
In a joint statement, companies stated, “Merck and Ridgeback Biotherapeutics have conducted a rigorous development program for molnupiravir, and believe that molnupiravir has the potential to address a significant unmet medical need for an oral medicine for adults with COVID-19 who are at risk for progressing to severe COVID-19 and/or hospitalization. We look forward to working with the FDA and other agencies as they review our applications.”
In this study population, molnupiravir reduced the risk of hospitalization or death from 9.7% in the placebo group to 6.8% in the molnupiravir group, for an absolute risk reduction of 3.0% and a relative risk reduction of 30%.
As per the earlier report at planned interim analysis, molnupiravir significantly reduced the risk of hospitalization or death from 14.1% in the placebo group to 7.3% in the molnupiravir group, for a relative risk reduction of 48%.
Merck has shared these additional analyses with the FDA and they will be presented to the FDA’s Antimicrobial Drugs Advisory Committee on Nov. 30th. Molnupiravir has already been authorized for use in the U.K. And the FDA is reviewing Merck’s application for Emergency Use Authorization.
We have earlier this month, reported that Sun Pharma is going to introduce Molnupiravir to treat covid infected adults in India.