If authorized, molnupiravir could be the first oral antiviral medicine to treat COVID-19.
On Monday, pharmaceutical giant Merck & Co Inc. announced its application for molnupiravir, its oral antiviral medication for Emergency Use Authorization (EUA) to the U.S Food and Drug Administration (FDA). The application places the drug in line to become the first oral antiviral medication for the treatment of mild to moderate COVID-19 in adults at risk for severe disease. The FDA authorization could bring about change to the clinical management of COVID-19 as the pill can be taken at home. The submission is based on positive results from an interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalization.
The results showed that molnupiravir reduced the risk of hospitalization or death by approximately 50%. “The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Merck CEO Robert Davis in a company press release. In June, the company entered into a procurement agreement with the U.S. government to supply about 1.7 million courses of molnupiravir upon EUA or FDA approval. In anticipation of a potential authorization, Merck said it has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021 and expects to increase that number in 2022.