MSD Announces European Medicines Agency Acceptance of Marketing Authorisation Application for Grazoprevir/Elbasvir, an Invest...
July 23 2015 - 11:02AM
Business Wire
MSD, known as Merck (NYSE:MRK) in the United States and Canada,
today announced the European Medicines Agency (EMA) has accepted
for review a marketing authorisation 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 timelines.
“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, a U.S.-based division of Merck & Co., Inc.,
Kenilworth, N.J., U.S.A. “We are pleased to be working with
regulatory authorities as we advance grazoprevir/elbasvir for
appropriate patients living with chronic hepatitis C around the
world.”
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 programme,
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
GT 1, 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 MSD’s investigational, once-daily,
single-tablet combination therapy consisting of grazoprevir (NS3/4A
protease inhibitor) and elbasvir (NS5A replication complex
inhibitor). As part of MSD’s broad clinical trials programme,
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 MSD
Today's MSD is a global health care leader working to help the
world be well. MSD is a tradename of Merck & Co., Inc., with
headquarters in Kenilworth, N.J., U.S.A. 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, programmes and partnerships.
Forward-Looking Statement of Merck & Co. Inc.,
Kenilworth, NJ, USA
This news release of Merck & Co., Inc., Kenilworth, NJ, USA
(the “company”) includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States 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 healthcare
legislation in the United States and internationally; global trends
toward healthcare 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
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
1 Grazoprevir is an HCV NS3/4A protease inhibitor and elbasvir
is an HCV NS5A replication complex inhibitor.
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