Merck Announces U.S. Food & Drug Administration Acceptance of New Drug Application for Grazoprevir/Elbasvir, an Investigation...
28 July 2015 - 8:30PM
Business Wire
Company Granted FDA Priority Review with
Target Action Date of January 28, 2016
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 New Drug Application for
grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily,
single-tablet combination therapy for the treatment of adult
patients infected with chronic hepatitis C virus (HCV) genotypes
(GT) 1, 4 or 6.1 The FDA granted Priority Review for
grazoprevir/elbasvir (100mg/50mg), with a Prescription Drug User
Fee Act (PDUFA) action date of January 28, 2016.
“The U.S. FDA’s Priority Review designation for
grazoprevir/elbasvir underscores how innovative treatment
approaches for chronic hepatitis C are still needed for many
patient populations,” said Dr. Roy Baynes, senior vice president of
clinical development, Merck Research Laboratories. “Our clinical
data for grazoprevir/elbasvir in broad and diverse patient
populations with chronic hepatitis C are very encouraging, and we
look forward to continuing our dialogue with the FDA to bring this
novel combination medicine to the appropriate patients with chronic
hepatitis C.”
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. Data from
these trials were previously presented at The International Liver
Conference 2015™. Collectively, these trials evaluated treatment
regimens of grazoprevir/elbasvir (100mg/50mg), with or without
ribavirin, in multiple genotypes (GT1, 4 and 6) including patient
populations who were previously treated, and those with cirrhosis
or certain co-morbidities (e.g., HIV/HCV co-infection, chronic
kidney disease stages 4 and 5).
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 those on opiate substitution
therapy.
In April 2015, the 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 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 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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