Benzinga | Jan 24, 2022 07:14AM EST

Merck's Gefapixant For Chronic Cough Slapped With FDA Complete Response Letter

The FDA has issued a Complete Response Letter (CRL) to Merck Co & Inc's (NYSE:MRK) gefapixant for refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.

* Gefapixant is an investigational, non-narcotic, orally administered selective P2X3 receptor antagonist.

* In March 2021, the FDA accepted gefapixant marketing application.

* In the CRL, the FDA requested additional information related to efficacy measurement.

* The CRL was not related to the safety of gefapixant. Merck is reviewing the letter and will meet with the agency to discuss the next steps.

* Last week, the Japan Ministry of Health, Labor and Welfare (MHLW) approved Lyfnua (gefapixant) 45 mg for adults with refractory or unexplained chronic cough.

* Outside of Japan, gefapixant is an investigational treatment and is still under review by other regulatory bodies.

* Price Action: MRK shares are down 0.38% at $79.68 during the premarket session on the last check Monday.