BRIEF—FDA AdCom votes against approval of Merck's gefapixant

The US Food and Drug Administration’s pulmonary-allergy drugs advisory committee (PADAC) on Friday held an advisory committee (AdCom) meeting to discuss US pharma giant Merck & Co’s P2X3 inhibitor, gefapixant in chronic cough.

Following a discussion period, the committee voted on the following question: “Does the evidence demonstrate that gefapixant provides a clinically meaningful benefit to adult patients with refractory or unexplained chronic cough, given the small reduction in cough frequency and results from PROs?”

The result of the vote was 12 “no” to 1 “yes” with the sole “yes” coming from the patient advocate, with the committee highlighting the limited marginal effectiveness of the drug over placebo as well as discordance between primary (cough reduction) and secondary (patient-reported outcomes) as their rationale.

While the AdCom committee appreciated the unmet medical need and relative low risk with gefapixant, the clinical benefit was too marginal to garner support.