FDA Expresses Concerns Over Merck's Chronic Cough Drug Efficacy Data, Expert Panel To Review
According to a report in the media, the U.S. Food and Drug Administration's (FDA) concerns regarding the efficacy data of Merck's chronic cough drug, gefapixant, were revealed in documents released ahead of an upcoming meeting of independent experts.
Reportedly, Merck had submitted additional data after the FDA rejected the drug in January of the previous year. The FDA panel of expert advisers is scheduled to meet on Friday to assess whether Merck's provided data demonstrates a clinically meaningful reduction in cough frequency for patients using gefapixant, the media report stated.
Gefapixant, designed to block receptors that stimulate nerves triggering the urge to cough, demonstrated a statistically significant reduction in cough frequency in higher doses during two late-stage trials. While the drug has gained approval in the European Union and Japan, the FDA's evaluation will play a crucial role in determining its fate in the U.S., where chronic cough remains an unmet medical need. The drug is marketed under the brand name Lyfnua in approved regions.
As per the report in the media, Merck's shares experienced a nearly 1 per cent decline, trading at USD101.2 in the wake of these concerns. Chronic cough affects approximately 10 per cent of the adult population globally, with about half of those patients lacking an identifiable cause for their condition. Currently, there are no FDA-approved therapies for chronic cough in the United States, the report added.
