Merck Announces European Medicines Agency Acceptance of Marketing Authorization Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Infection


July 23, 2015 10:02 am ET

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced the European Medicines Agency (EMA) has accepted for
review a marketing authorization application (MAA) for
grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily,
single-tablet combination therapy for the treatment of adult patients
with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or 6 infection.1
The EMA will initiate review of the MAA under accelerated assessment

“Given the diversity of patient populations affected by chronic
hepatitis C, including the estimated 15 million people living with the
disease in Europe, it is important to provide patients and physicians
with treatment options,” said Dr. Roy Baynes, senior vice president of
clinical development, Merck Research Laboratories. “We are pleased to be
working with regulatory authorities as we advance grazoprevir/elbasvir
for appropriate patients living with chronic hepatitis C around the

The EMA’s accelerated assessment is available for products that respond
to unmet medical needs or represent a significant improvement over
current treatment options within a major public health interest, such as
the treatment of chronic HCV infection. The Committee for Medicinal
Products for Human Use (CHMP) will continue to evaluate the accelerated
assessment status throughout the MAA evaluation process.

The MAA for grazoprevir/elbasvir (100mg/50mg) is based in part upon data
from the pivotal C-EDGE clinical trials program, as well as the C-SURFER,
C-SALVAGE and C-SWIFT clinical trials, evaluating
grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in
patients with chronic HCV infection. Collectively, these trials
evaluated treatment regimens in multiple genotypes (GT1, 3, 4 and 6),
including patient populations who were previously treated, and those
with cirrhosis or certain co-morbidities (i.e., HIV co-infection,
chronic kidney disease stages 4 and 5).

The company submitted a New Drug Application for grazoprevir/elbasvir
(100mg/50mg) to the U.S. Food and Drug Administration (FDA) in May 2015
for the treatment of chronic HCV GT1, 4 or 6 infection, and is
submitting additional license applications in other markets by the end
of 2015. In April 2015, the U.S. FDA granted Breakthrough Therapy
designation status for grazoprevir/elbasvir for the treatment of
patients infected with chronic HCV GT1 with end stage renal disease on
hemodialysis, and Breakthrough Therapy designation status for
grazoprevir/elbasvir for the treatment of patients infected with chronic
HCV GT4. Breakthrough Therapy designation is intended to expedite the
development and review of a candidate that is planned for use, alone or
in combination, to treat a serious or life-threatening disease or
condition when preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapies on one or
more clinically significant endpoints.

About Grazoprevir/Elbasvir

Grazoprevir/elbasvir is Merck’s investigational, once-daily,
single-tablet combination therapy consisting of grazoprevir (NS3/4A
protease inhibitor) and elbasvir (NS5A replication complex inhibitor).
As part of Merck’s broad clinical trials program, grazoprevir/elbasvir
is being evaluated in multiple HCV genotypes including patients with
difficult-to-treat conditions such as HIV/HCV co-infection, advanced
chronic kidney disease, inherited blood disorders, liver cirrhosis, and
in those on opiate substitution therapy.

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 YouTube.

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“company”) includes “forward-looking statements” within the meaning of
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1 Grazoprevir is an HCV NS3/4A protease inhibitor and
elbasvir is an HCV NS5A replication complex inhibitor.

Merck & Co., Inc.
Doris Li, 908-246-5701
Sarra Herzog, 201-669-6570
Joe Romanelli, 908-740-1986
Justin Holko, 908-740-1879

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