Merck Provides U.S. Regulatory Update on Gefapixant
20 Dezembro 2023 - 6:30PM
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).
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