Merck: FDA Rejects Gefapixant Application, Requests More Data
24 January 2022 - 11:34PM
Dow Jones News
By Colin Kellaher
Merck & Co. on Monday said the U.S. Food and Drug
Administration has turned away the drugmaker's application seeking
approval of gefapixant for the treatment of refractory chronic
cough or unexplained chronic cough in adults, and the agency is
seeking additional information.
The Kenilworth, N.J., company said the FDA issued a so-called
complete-response letter, indicating that it won't approve the
application in its current form.
Merck said the FDA requested more information related to
measurement of efficacy, adding that the letter wasn't related to
the safety of gefapixant. Merck said it is reviewing the letter and
will meet with the FDA to discuss its next steps.
There are currently no FDA-approved therapies for the treatment
of refractory or unexplained chronic cough.
Merck said Japan's Ministry of Health Labor and Welfare last
week approved gefapixant, which it will market as Lyfnua, for
adults with refractory or unexplained chronic cough.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 24, 2022 07:19 ET (12:19 GMT)
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