The experimental COVID-19 antiviral pill molnupiravir is on track to receive federal emergency use authorization.
Merck and Ridgeback Biotherapeutics on Monday submitted an EUA application for the pill to the Food and Drug Administration. If authorized, certain patients could take the drug at home after a COVID-19 diagnosis, its developers said.
The steps toward authorizing what would be the first oral antiviral COVID-19 treatment on the market are moving at a fast clip — with the application news coming 10 days after the companies announced promising trial data.
Molnupiravir was tested in at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19, cutting the rate of hospitalization or death by 50% in people with COVID-19 when compared to placebo.
To date, remdesivir (Veklury) is the only antiviral drug that has been approved in the United States for the treatment of COVID-19. In contrast with molnupiravir, it is recommended for use in severely ill, hospitalized patients and must be delivered intravenously.
The U.S. government will purchase 1.7 million courses of the drug if the FDA approves an EUA, which grants limited clinical use during the pandemic. Drugs given EUA status are subject to further regulatory vetting if their makers wish to apply for full approval.
“The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics.