Merck Provides U.S. and Japan Regulatory Update for Gefapixant

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today 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 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. In the CRL, the FDA requested additional information related to measurement of efficacy. 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,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “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.”

Last week, the Japan Ministry of Health, Labor and Welfare (MHLW) approved LYFNUA® (gefapixant) Tablets 45 mg for adults with refractory or unexplained chronic cough. In Japan, LYFNUA is the planned trademark for gefapixant; the trademark for gefapixant in other countries has not been approved. Outside of Japan, gefapixant is an investigational treatment and is still under review by other regulatory bodies.

Más del autor

Artículos relacionados

Lo más reciente

Walmart To Host One-Weekend-Only Savings Event Exclusively for Walmart+ Members

Today, Walmart announced the arrival of Walmart+ Weekend, an online savings event exclusively for Walmart+ members that stretches over three days. The fun begins on...

Citizens Financial Group Announces Pricing of $400 Million of its Subordinated Notes and $650 Million of Citizens Bank, N.A. Senior Notes

Citizens Financial Group, Inc. (NYSE: CFG) today announced the pricing of concurrent unsecured note offerings by CFG and its banking subsidiary Citizens Bank, N.A....

Cirium se asocia con 3Victors para ofrecer la previsión más dinámica de la demanda de viajes

Cirium, la empresa de análisis de aviación, y la empresa de análisis de datos turísticos, 3Victors anunciaron hoy una asociación de revendedores que le...

¿Quieres recibir las notas de mayor interés en tu email?

Comparte con nosotros tu email y te haremos llegar las noticias de mayor relevancia directo a tu correo