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FDA passes on gefapixant for chronic cough
On December 20, Merck announced that the FDA has rejected the company’s NDA for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. In the CRL, FDA concluded that Merck’s application failed to meet substantial evidence of effectiveness for treating RCC and UCC, Merck said in a press release. The CRL wasn’t related to the safety of gefapixant.
Chronic cough is defined as a cough lasting >8 weeks. In adults with RCC, the cough persists despite addressing underlying conditions such as asthma or GERD, while UCC is a cough where the underlying cause can't be identified despite a thorough work-up.
FDA’s decision comes approximately a month after FDA’s Pulmonary-Allergy Drugs Advisory Committee voted nearly unanimously against approval of the drug.
Source:
Merck & Co. (2023, December 20). Merck Provides U.S. Regulatory Update on Gefapixant. [Press release]. https://www.merck.com/news/merck-provides-u-s-regulatory-update-on-gefapixant/