Another Regulatory No-Go on Merck’s Second Try With Gefapixant

Merck appears destined for another disappointment with its investigative cough suppressant gefapixant, after an FDA advisory committee almost universally panned the drug’s phase 3 data, citing an almost complete overlap of patient-reported outcomes, a 57 percent placebo response rate, and a 28 percent dropout rate related to taste disturbance, the drug’s biggest side effect.

All clinician members of the Pulmonary-Allergy Drugs Advisory Committee voted against gefapixant at the committee’s meeting on Friday, saying there wasn’t enough solid evidence to support an approval. The sole yes vote came from the only patient representative on the committee.

It’s the second regulatory blow in the U.S. for gefapixant. Although the drug was approved in Japan in 2022, the FDA refused to follow suit, instead issuing a Complete Response Letter that questioned one of the cough recording measures in the pivotal data.

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