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.

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