Merck Receives First Approval for Oral Antiviral to Treat COVID-19

UK regulatory authorities approved molnupiravir to treat patients with mild-to-moderate COVID-19.

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has authorized molnupiravir, the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19. Developed by Merck and Ridgeback Biotherapeutics, the therapy will have the brand name Lagevrio in the UK.

The authorization is based on positive results from a planned interim analysis from the phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir 800 mg twice-daily in non-hospitalized, unvaccinated adult patients with mild-to-moderate COVID-19. Molnupiravir reduced the risk of hospitalization or death by about 50%. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared with eight deaths in patients who received placebo. The incidence of any adverse event was comparable in the molnupiravir and placebo groups.

Last month Merck submitted its application to the FDA, and an FDA advisory committee will meet on Nov. 30, 2021, to discuss an emergency use authorization for molnupiravir. Merck has also submitted an application for molnupiravir to the European Medicines Agency.

The company expected to produce 10 million courses of treatment by the end of 2021, with at least 20 million courses to be produced in 2022.Earlier this year, Merck entered into an agreement with the U.S. government to supply about 1.7 million courses of the COVID-19 treatment.

Related: Merck will Provide Access to COVID-19 Treatment in Low-Income Countries

Molnupiravir was invented at Emory University and licensed to Ridgeback Biotherapeutics by Drug Innovation Ventures at Emory. It is being develop by Merck in collaboration with Ridgeback.

“When we embarked on the journey to take molnupiravir from a hope to a reality, we believed we had a responsibility to move as quickly and safely as possible. We believed each day saved could save lives and limit severe disease and the global hardships of this pandemic,” Wendy Holman, chief executive officer, Ridgeback Biotherapeutics, said in a statement.