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

01-24-22 0719ET