Merck, Ridgeback: EMA Begins Rolling Review of Covid-19 Pill
October 25 2021 - 6:55AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 25, 2021 06:40 ET (10:40 GMT)
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