FDA raises concerns over efficacy of Merck's potential chronic cough drug ahead of adcomm
The FDA’s Pulmonary-Allergy Drugs Advisory Committee will meet Friday to discuss Merck’s application for its chronic cough oral drug gefapixant, with the agency saying the key issue is uncertainty about its benefit.
In briefing documents released Wednesday, the FDA said there was a “small” reduction in coughing frequency compared to a high response in the placebo group and “limited” supportive evidence from patient-reported outcomes. Side effects are also a part of the concern, with the agency noting a high rate of taste disturbance.
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