Merck & Co’s application for a new drug meant to treat chronic cough in adults was declined by the U.S. FDA, as the agency seeks additional information on its effectiveness.
The drugmaker was pursuing approval for a new drug called gefapixant, an orally administered investigative drug to treat refractory chronic cough (RCC) or unexplained chronic cough (UCC). While the denial — issued in a CRL to Merck — was not due to safety concerns related to gefapixant, the FDA requested more information related to the measurement of efficacy before approval could be granted.
According to Merck, the company is reviewing the letter and plans to meet with the agency to discuss the next steps. Merck, headquartered in Kenilworth, New Jersey, will continue working to advance the drug for patients with chronic cough, said Dr. Roy Barnes, senior vice president and CMO of Merck Research Laboratories.
“We believe there is a significant unmet need to help patients manage their chronic cough, as there are no available treatment options indicated in the U.S. specifically for this condition,” Barnes added. The FDA accepted Merck’s NDA for gefapixant back in March 2021.
The Japanese Ministry of Health, Labor, and Welfare approved Lyfuna — the planned trademark for gefapixant — for adults with RCC or UCC. In other countries, Lyfuna is still an investigational treatment under review.