Publication of phase III study of molnupiravir, an investigational oral antiviral COVID-19 treatment, in the New England Journal of Medicine.- Merck Inc., + Ridgeback Biotherapeutics.
Data from MOVe-OUT demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19. Merck Inc., is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.
Molnupiravir is authorized in the United Kingdom as the first oral antiviral for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. The European Medicines Agency (EMA) issued a positive scientific opinion for molnupiravir under Article 5.3 Regulation 726/2004, which is intended to support national decision-making on the possible use of molnupiravir prior to marketing authorization. Regulatory applications are under review or are in the process of being submitted, including applications for Emergency Use Authorization (EUA) by the FDA and Japan’s Ministry of Health, Labor and Welfare.
“In MOVe-OUT, molnupiravir significantly reduced the risk of hospitalization and death among a diverse population of patients at risk for more severe COVID-19. The increases in COVID-19 cases, hospitalizations and deaths being reported globally are a stark reminder that new tools are urgently needed, which is why we are moving with speed and rigor to obtain authorizations and to accelerate broad global access to this investigational medicine for appropriate patients,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “Importantly, we observed consistent efficacy among patients with more common variants at the time, and more recent preclinical evidence indicates that molnupiravir has antiviral activity against Omicron, which is encouraging considering the uncertain future of a rapidly evolving virus such as SARS-CoV-2.”
See-"Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients"- Angélica Jayk Bernal, M.D., Monica M. Gomes da Silva, M.D., Dany B. Musungaie, M.D., Evgeniy Kovalchuk, M.D., et al., for the MOVe-OUT Study Group-December 16, 2021 DOI: 10.1056/NEJMoa2116044.
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