Merck Announces Initiation Of Rolling Review By EMA For Molnupiravir For COVID-19 Treatment

(RTTNews) - Merck & Co., Inc. (MRK) and Ridgeback Biotherapeutics said that the European Medicines Agency or EMA has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the treatment of COVID-19 in adults. Merck said it plans to work with the EMA's Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application.

If granted marketing authorization by the European Commission, molnupiravir could be the first oral antiviral medicine for the treatment of COVID-19 in the European Union.

On October 11, Merck and Ridgeback announced that Merck had submitted an application for Emergency Use Authorization to the U.S. FDA for molnupiravir for the treatment of at-risk adults with mild-to-moderate COVID-19. Additional submissions to global regulatory agencies are underway.