EMA starts rolling review of Merck COVID drug

Monday, 25. October 2021 12:19

European Medicines Agency's human medicines committee (CHMP) started on Monday a rolling review of the COVID-19 oral medicine molnupiravir, developed by Merck & Co. Inc. and Ridgeback Biotherapeutics, for the treatment of adults.

The EMA stated that laboratory non-clinical data and clinical studies "suggest that the medicine may reduce the ability of SARS CoV 2... to multiply in the body, thereby preventing hospitalisation or death in patients with COVID-19," adding that "the rolling review will continue until enough evidence is available for the company to submit a formal marketing authorisation application."

The European drug regulator also said that expected timelines for potential approval cannot be set at this time.

Related Links: Merck & Co. Inc.
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Breaking the News / MS