Merck's Gefapixant Under FDA Lens: Advisory Committee To Discuss Chronic Cough Drug's Future

The FDA's Pulmonary-Allergy Drugs Advisory Committee will convene Friday to discuss Merck & Co Inc's MRK marketing application seeking approval for chronic cough oral drug gefapixant.

The U.S. health regulator raised the concerns after Merck had submitted additional efficacy data.

In January last year, the FDA declined to approve the drug. 

However, the European Union and Japan have approved Merck's drug for chronic cough, which is sold under the brand Lyfnua.

In briefing documents released Wednesday, the FDA noted that treatment with gefapixant showed a small reduction in cough frequency and has questions about whether the effect is clinically meaningful. 

In one study, 45 mg of gefapixant reduced the 24-hour cough frequency by 18.45% (p=0.041) relative to placebo. In a second study, 45 mg of the drug reduced the 24-hour cough frequency by 14.64% (p=0.031) relative to placebo.

In the gefapixant 45 mg arm, 22.3% of subjects discontinued treatment, compared to 7.9% in the 15 mg group and 5.6% in the placebo arm. Taste-related adverse events led to early treatment discontinuation in 14% of subjects in the highest dose group of 45 mg.

"While the gefapixant clinical program did not identify serious safety concerns from its use, a favorable benefit-risk profile cannot be concluded if there is no meaningful benefit of the therapy to patients," the FDA wrote.

The adcomm members will discuss whether "the available data support that treatment with gefapixant provides a clinically meaningful benefit for adult patients with refractory or unexplained chronic cough," given "the small reduction in cough frequency with gefapixant treatment, the observed results from patient-reported outcomes, and the potential unblinding of patients due to taste disturbance."

Price Action: MRK shares are down 0.1% at $101.24 at the last check Thursday.

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