Merck’s oral COVID-19 pill receives world-first authorisation

Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics have announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorisation in the United Kingdom (UK) for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral medicine authorised 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. In the UK, LAGEVRIO is the planned trademark for molnupiravir; the trademark for molnupiravir in other countries has not been approved. Merck announced its application with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of molnupiravir is under review and recently the European Medicines Agency has initiated a rolling review of the company’s Marketing Authorisation Application. Merck is actively working to submit applications to other regulatory agencies around the world.