Merck, on Monday, announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for Gefapixant. The FDA has requested the pharma firm to provide additional information related to the measurement of the efficacy of the drug.
Gefapixant is the investigational, non-narcotic, orally administered selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.
In March 2021, Merck announced that the FDA accepted the company’s NDA for gefapixant. Merck, in its recent statement stated, ‘The CRL was not related to the safety of gefapixant. Merck is reviewing the letter and will meet with the agency to discuss next steps.’
“We remain committed to advancing gefapixant for patients with refractory or unexplained chronic cough and will work with the FDA to address the agency’s feedback. 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.”Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. “
Last week, the Japan Ministry of Health, Labor, and Welfare approved Gefapixant Tablets named LYFNUA for adults with refractory or unexplained chronic cough. Gefapixant is an investigational treatment and is still under review by other regulatory bodies outside of Japan.