Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention...
January 27 2016 - 8:30AM
Business Wire
FDA Grants Priority Review with Target
Action Date of July 23, 2016
Marketing Authorization Application Also
Filed with the European Medicines Agency
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that the U.S. Food and Drug Administration
(FDA) has accepted for review the Biologics License Application
(BLA) for bezlotoxumab, an investigational antitoxin for prevention
of Clostridium difficile (C. difficile) infection recurrence. The
FDA granted Priority Review for bezlotoxumab, with a Prescription
Drug User Fee Act (PDUFA) action date of July 23, 2016.
The company also has filed a marketing authorization application
for bezlotoxumab with the European Medicines Agency (EMA) that is
currently under review.
“Recurrence is a major challenge with C. difficile infection,
one of the most common healthcare-associated infections in U.S.
hospitals,” said Dr. Roy Baynes, senior vice president of clinical
development, Merck Research Laboratories. “Currently, there are no
therapies approved for the prevention of C. difficile infection
recurrence. As part of Merck’s commitment to the fight against
infectious diseases, we look forward to continuing to work with the
FDA and EMA to bring forward this novel medicine for appropriate
patients.”
The application for bezlotoxumab is based in part on data from
the pivotal MODIFY I and MODIFY II clinical trials. Data from these
trials were previously presented at the Interscience Conference of
Antimicrobial Agents and Chemotherapy (ICAAC) and International
Congress of Chemotherapy and Infection (ICC) 2015 joint
meeting.
About bezlotoxumab
Bezlotoxumab is an investigational antitoxin given in
conjunction with standard of care antibiotics that are used in the
treatment of C. difficile infection. It is not an antibiotic.
Bezlotoxumab is designed to neutralize C. difficile toxin B, a
toxin that can damage the gut wall and cause inflammation, leading
to C. difficile-associated diarrhea.
About Merck
Today's Merck is 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, NJ, 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 2014
Annual Report on Form 10-K and the company’s other filings with the
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MerckMedia:Pamela Eisele, 267-305-3558Robert Consalvo,
908-236-1127orInvestors:Teri Loxam, 908-740-1986Amy Klug,
908-740-1898
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