{"id":55024,"date":"2024-12-20T10:28:40","date_gmt":"2024-12-20T10:28:40","guid":{"rendered":"https:\/\/prosfunds.com\/?p=55024"},"modified":"2024-12-20T10:28:45","modified_gmt":"2024-12-20T10:28:45","slug":"fda-panel-flags-insufficient-data-for-mercks-chronic-cough-drug-by-reuters","status":"publish","type":"post","link":"https:\/\/prosfunds.com\/?p=55024","title":{"rendered":"FDA panel flags insufficient data for Merck’s chronic cough drug By Reuters"},"content":{"rendered":"
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By Khushi Mandowara and Christy Santhosh<\/p>\n

(Reuters) -Advisers to the U.S. health regulator said on Friday that data on Merck’s chronic cough drug does not provide sufficient evidence to prove its clinical benefit for patients.<\/p>\n

The U.S. Food and Drug Administration’s (FDA) panel voted 12 to 1 against the late-stage data submitted by Merck for the drug gefapixant, which showed a small reduction in cough frequency compared to a placebo.<\/p>\n

Patients who received the treatment also experienced side effects such as loss of taste.<\/p>\n

While the FDA advisers said side effects from use of the drug were manageable, they questioned the effectiveness of the drug citing a high number of patients who dropped out of the study.<\/p>\n

Late-stage data from Merck showed 22% patients treated with high dose of the drug discontinued the treatment due to adverse events.<\/p>\n

“If they were feeling so much benefit would they have dropped out … if that’s how many (patients) are dropping out in trial, I would expect to see a bigger drop out rate in the real world,” FDA adviser Emma D’Agostino, a consultant at Cystic Fibrosis Foundation, said.<\/p>\n

The panel’s vote could further delay the regulatory path for Merck’s drug, which the FDA has already declined to approve once last year.<\/p>\n

Merck said it disagreed with the committee as the data showed a meaningful clinical benefit for adults with refractory or unexplained chronic cough.<\/p>\n

FDA, which generally follows the advise of its panel, but is not bound to do so, will make a decision on the drug by Dec. 27.<\/p>\n<\/p>\n

If approved, 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.<\/p>\n

Currently, there are no FDA-approved therapies for chronic cough, which Merck said affects about 5% to 10% of the global adult population.<\/p>\n<\/p><\/div>\n