Merck Submits U.S. New Drug Application for Grazoprevir/Elbasvir, an Investigational Once-Daily, Single Tablet Combination Th...
May 28 2015 - 4:30PM
Business Wire
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that the company has submitted a New Drug
Application to the U.S. Food and Drug Administration (FDA) for
grazoprevir/elbasvir (100mg/50mg), an investigational once-daily,
single tablet combination therapy for the treatment of adult
patients with chronic hepatitis C genotypes (GT) 1, 4 or 6
infection. Within 60 days of submission, the FDA will determine
whether it will accept for review Merck's application as filed. The
company plans to submit additional license applications in the
European Union and other markets by the end of 2015.
“Merck's submission is based on evidence from our wide-ranging
clinical program assessing the efficacy and tolerability profile of
grazoprevir/elbasvir in populations with chronic hepatitis C,” said
Dr. Roy Baynes, senior vice president of clinical development,
Merck Research Laboratories. “This submission to the U.S. FDA is an
important milestone as we seek to provide patients with a new
treatment option for this serious infection.”
The FDA has previously 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 for 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.
The New Drug Application 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 and C-SALVAGE trials,
evaluating grazoprevir/elbasvir (100mg/50mg), with or without
ribavirin, in patients with chronic hepatitis C infection. Data
from these trials were presented at The International Liver
CongressTM 2015 in April 2015.
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, once-daily single
tablet regimen 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 studied in multiple HCV genotypes and in patients with
difficult-to-treat conditions such as HIV/HCV co-infection,
advanced chronic kidney disease, inherited blood disorders, liver
cirrhosis and 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, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release 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 Merck’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; Merck’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 Merck patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise except as required by applicable law.
Additional factors that could cause results to differ materially
from those described in the forward-looking statements can be found
in Merck’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).
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MerckMedia:Doris Li, 908-246-5701orSarra Herzog,
908-740-1871orInvestors:Joe Romanelli, 908-740-1986orJustin Holko,
908-740-1879
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