Merck, Ridgeback : EMA Begins Rolling Review of Covid-19 Pill

By Colin Kellaher

Merck & Co. and Ridgeback Biotherapeutics on Monday said the European Medicines Agency has initiated a rolling review for molnupiravir, their investigational oral treatment of Covid-19 in adults.

Merck said it plans to work with the agency's Committee for Medicinal Products for Human Use to complete the rolling review process to facilitate initiating the formal review of a marketing authorization application for the antiviral drug.

Merck and partner Ridgeback earlier this month filed for U.S. Food and Drug Administration emergency-use authorization for molnupiravir, a key step toward adding a long-sought Covid-19 drug for use at home.

The filings by Merck and Ridgeback come after data from a late-stage study showed that molnupiravir cut the risk of hospitalization or death by about 50% in high-risk people with mild to moderate Covid-19.

Merck said it is working to submit applications for the drug to other regulatory agencies worldwide.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

10-25-21 0640ET