Merck (NYSE:MRK) reported that the FDA has issued a complete response letter (CRL) for its oral P2X3 receptor antagonist, gefapixant, seeking approval to treat refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. The FDA concluded that the data provided did not offer sufficient evidence to demonstrate the drug’s clinical benefit for these conditions. While the CRL raised no safety concerns, it aligns with the negative recommendation from an FDA advisory committee last month.
This marks the second CRL for gefapixant, with the FDA requesting additional information on efficacy measurement in the previous one. Merck is reviewing the feedback to determine the next steps. In contrast, gefapixant received approval in the EU as Lyfnua and in Japan earlier this year.
Chronic cough, lasting over eight weeks, lacks approved treatments for RCC or UCC in the U.S. GSK plc (GSK) stands to benefit, evaluating its chronic cough drug, camlipixant, in late-stage development. GSK, acquiring Bellus Health, aims to launch its RCC drug commercially by 2026.
Merck’s shares have declined by 5.0% year-to-date, while GSK is poised for progress in the investigational chronic cough drug space.
Featured Image: Megapixl @ Michaelvi
Author Stephanie Bédard-Châteauneuf 
