© Reuters. FILE PHOTO: The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid/File Photo
(Reuters) – The U.S. health regulator’s advisers said on Friday that data on Merck’s chronic cough drug gefapixant does not provide sufficient evidence to prove its clinical benefit for patients.
The FDA panel voted 12 to 1 against the data submitted by Merck, which showed a small reduction in cough frequency and side effects such as loss of taste in patients who received the treatment.
The panel’s decision comes as a setback for Merck. The company has been involved in discussions with the health agency on the effectiveness of gefapixant for years.
Merck’s drug is up against GSK-owned camlipixant, which is in late-stage development for the treatment of chronic cough with anticipated regulatory approval and launch in 2026.
The FDA generally follows the advise of its panel, but is not bound to do so.
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