Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence


January 27, 2016 8:30 am ET

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
(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.
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

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,
and connect with us on Twitter,
and LinkedIn.

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“company”) includes “forward-looking statements” within the meaning of
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Pamela Eisele, 267-305-3558
Robert Consalvo, 908-236-1127
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898

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