Merck, Ridgeback submit EUA application for COVID antiviral

Oct. 11, 2021

Merck (MSD) and Ridgeback Biotherapeutics announced that Merck has submitted an Emergency Use Authorization application to the U.S. FDA for molnupiravir, an investigational oral antiviral medicine for the treatment of mild-to-moderate COVID-19 — just 10 days after posting positive phase 3 data.

The submission is based on positive results from a planned interim analysis from the MOVe-OUT clinical trial, which found that molnupiravir reduced the risk of hospitalization or death by approximately 50% in at-risk, non-hospitalized adult patients with mild-to-moderate COVID.

“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 Robert M. Davis, Merck's chief executive officer and president, in the press announcement.

Merck has wasted no time building its supply of the drug. According to the company, banking on the potential for regulatory authorization, Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with more courses expected to be produced in 2022.

Earlier this year, Merck entered into a procurement agreement with the U.S. Government under which the company will supply approximately 1.7 million courses of molnupiravir to the government upon EUA or approval from the U.S. FDA. Additionally, Merck has entered into supply and advance purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other countries to add to that list.