Merck Provides U.S. and Japan Regulatory Update for Gefapixant
24 Januar 2022 - 12:45PM
Business Wire
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.
About Chronic Cough The prevalence of chronic cough (a
cough lasting more than 8 weeks) is estimated to be approximately
5% of adults in the U.S. In a subset of these cases, patients
either do not respond to treatment of underlying conditions (such
as asthma or gastroesophageal reflux), known as refractory chronic
cough (RCC), or they have no identifiable underlying condition
despite a thorough evaluation, known as unexplained chronic cough
(UCC). There are currently no approved therapies for the treatment
of RCC or UCC in the U.S.
About Merck For over 130 years, Merck, known as MSD
outside the United States and Canada, has been inventing for life,
bringing forward medicines and vaccines for many of the world’s
most challenging diseases in pursuit of our mission to save and
improve lives. We demonstrate our commitment to patients and
population health by increasing access to health care through
far-reaching policies, programs and partnerships. Today, Merck
continues to be at the forefront of research to prevent and treat
diseases that threaten people and animals – including cancer,
infectious diseases such as HIV and Ebola, and emerging animal
diseases – as we aspire to be the premier research-intensive
biopharmaceutical company in the world. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, Instagram,
YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA This news release of Merck & Co.,
Inc., Kenilworth, 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 2020
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220124005238/en/
Media:
Melissa Moody (215) 407-3536 Sienna Choi (908) 873-4311
Investors:
Peter Dannenbaum (908) 740-1037 Alexis Constantine (908)
740-1051
Merck (NYSE:MRK)
Historical Stock Chart
Von Mär 2024 bis Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
Von Apr 2023 bis Apr 2024