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Merck Provides U.S. Regulatory Update on Gefapixant
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Merck (MRK) receives Complete Response Letter from FDA for gefapixant NDA, citing lack of substantial evidence for effectiveness in treating refractory chronic cough (RCC) and unexplained chronic cough (UCC) in adults.
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FDA issues Complete Response Letter citing lack of substantial evidence for effectiveness in treating RCC and UCC in adults
RAHWAY, N.J.--(BUSINESS WIRE)--
Merck (NYSE: MRK), known as MSD outside of 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, 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, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating RCC and UCC. The CRL was not related to the safety of gefapixant. Merck is reviewing the FDA’s feedback to determine next steps.
Chronic cough is defined as a cough lasting longer than 8 weeks. In adults with RCC, the cough persists despite appropriate treatment of underlying conditions such as asthma or gastroesophageal reflux disease, and UCC is a cough where the underlying cause cannot be identified despite a thorough evaluation.
“We thank our clinical trial participants and investigators for their important contributions that add to the body of knowledge related to chronic cough and help to raise awareness about the significant unmet medical need and the impact of RCC and UCC on patients,” said Dr. Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories. “Acknowledging the absence of any approved treatments for refractory or unexplained chronic cough, we are disappointed in the FDA’s response to our application for gefapixant.”
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
What is the latest announcement from Merck (MRK) regarding gefapixant?
Merck (MRK) received a Complete Response Letter from the FDA for its New Drug Application for gefapixant, indicating that it did not meet substantial evidence of effectiveness for treating refractory chronic cough and unexplained chronic cough in adults.
What is the FDA's feedback on Merck's gefapixant NDA?
The FDA concluded that Merck's application did not meet substantial evidence of effectiveness for treating RCC and UCC in adults.
What is the definition of chronic cough?
Chronic cough is defined as a cough lasting longer than 8 weeks, persisting despite appropriate treatment of underlying conditions such as asthma or gastroesophageal reflux disease.
What are the implications of the FDA's Complete Response Letter for Merck (MRK)?
The CRL indicates that Merck's application for gefapixant did not meet substantial evidence of effectiveness for treating RCC and UCC in adults, prompting a review of the FDA's feedback to determine next steps.
What are the potential next steps for Merck (MRK) following the FDA's Complete Response Letter?
Merck is reviewing the FDA's feedback to determine next steps regarding the development and potential approval of gefapixant for the treatment of refractory chronic cough and unexplained chronic cough in adults.
