Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab
July 21 2016 - 4:30PM
Business Wire
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today said that the U.S. Food and Drug Administration (FDA)
has requested the submission of new data and analyses from the
MODIFY I and MODIFY II clinical trials previously submitted to the
pending Biologics Licensing Application (BLA) for bezlotoxumab, an
investigational agent for prevention of Clostridium difficile (C.
difficile) infection recurrence. The additional data and analyses
constitute a major amendment to the BLA, resulting in an extension
of the Prescription Drug User Fee Act (PDUFA) goal date by three
months. The new goal date will be Oct. 23, 2016.
The FDA granted Priority Review designation to the bezlotoxumab
BLA, with an original PDUFA goal date of July 23, 2016. On June 9,
the Antimicrobial Drugs Advisory Committee of the FDA voted
10-to-5, with one abstention, in support of bezlotoxumab as showing
substantial evidence of efficacy and safety in preventing the
recurrence of C. difficile infection.
Merck looks forward to continuing to work with the FDA on the
review of the bezlotoxumab BLA.
About Merck
For 125 years, Merck has been a global health care leader
working to help the world be well. Merck is known as MSD outside
the United States and Canada. Through our prescription medicines,
vaccines, biologic therapies, and animal health products, we work
with customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to
increasing access to health care through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, 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 products that
the products 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 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 2015
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).
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version on businesswire.com: http://www.businesswire.com/news/home/20160721006295/en/
MerckMedia:Pamela Eisele, 267-305-3558Robert Consalvo,
908-236-1127orInvestors:Teri Loxam, 908-740-1986Amy Klug,
908-740-1898
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