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Merck Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Genotypes 1, 4 and 6 Infection
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Company Granted FDA Priority Review with Target Action Date of January 28, 2016
Tuesday, July 28, 2015 6:30 am EDT
KENILWORTH, N.J.--(BUSINESS WIRE)--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).
NATAP: Merck at EASL 2015 - (05/22/15)
EASL: Merck HCV Nuk MK3682 7-Day Monotherapy - (05/05/15)
AASLD/2014: MK-8408, a Potent and Selective NS5A Inhibitor With a High Genetic Barrier to Resistance and Activity Against HCV Genotypes 1-6 - (11/12/14)
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
Contact:
Merck
Media:
Doris Li, (908) 246-5701
Sarra Herzog, (201) 669-6570
or
Investor:
Joe Romanelli, (908) 740-1986
Justin Holko, (908) 740-1879
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