Merck's Latest Drug For Chronic Cough Faces FDA Pushback

A panel of advisors to the Food and Drug Administration (FDA) reportedly expressed concerns about the efficacy of Merck & Company, Inc.'s MRK new drug gefapixant, intended to treat chronic cough. 

The panel highlighted a lack of convincing evidence to support the drug's clinical benefits for patients, casting doubt on its potential approval. 

The FDA panel, with a 12 to 1 vote, questioned the late-stage data submitted by Merck, pointing out only a minor reduction in cough frequency compared to a placebo, according to Reuters.

The advisory panel also scrutinized the side effects experienced by patients, including loss of taste, the report added. 

Despite acknowledging that the side effects were manageable, the experts remained unconvinced about the drug's overall effectiveness. This skepticism was further fueled by a high dropout rate in the study, with 22% of patients discontinuing the high-dose treatment due to adverse events. 

FDA adviser Emma D'Agostino raised concerns about the real-world implications of this dropout rate.

"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," D'Agostino said, according to Reuters. 

However, Merck defended its drug, insisting that the data demonstrated significant clinical benefits for adults with refractory or unexplained chronic cough. 

The panel's vote could delay the regulatory pathway for gefapixant, which the FDA had previously declined to approve last year, according to the report. 

The FDA, set to make its decision by December 27, typically follows the advice of its panel but is not obliged to do so, the report added.

Competition And Market Potential

If approved, gefapixant will compete with GSK Plc GSK-owned camlipixant, currently in late-stage development for chronic cough treatment, Reuters added. 

With no FDA-approved therapies currently available for chronic cough — a condition affecting 5% to 10% of the global adult population — the market potential for these drugs is significant, Reuters reported.

In a related development, FDA approved Merck's blockbuster cancer drug for a specific type of gastric cancer, indicating the company's ongoing research and development efforts in various therapeutic areas.

Price Action: MRK shares closed lower by 0.24% to $101.75 on Friday.

This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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