ZontivityTreatment for Cardiovascular Risk Reduction
Update: Zontivity (vorapaxar) Now FDA Approved - May 8, 2014
Merck Statement on FDA Advisory Committee for Vorapaxar, Merck’s Investigational Antiplatelet Medicine
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today said it was pleased with the U.S. Food and Drug Administration (FDA)’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar. Vorapaxar is the company’s investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no history of stroke or transient ischemic attack.
“There are approximately 7.6 million Americans who have survived a heart attack. Each year, about 190,000 of them have a recurrent heart attack, so there remains a need for additional treatment options,” said Dr. Daniel Bloomfield, vice president, Cardiovascular Diseases, Merck Research Laboratories. “The results of today’s Advisory Committee mark an important milestone in our effort to bring vorapaxar to appropriate patients with a history of heart attack. We look forward to working with the FDA as it completes its review.”
The FDA is not bound by the Committee’s guidance, but takes its advice into consideration when reviewing investigational medicines.
Vorapaxar, proposed trade name Zontivity™, is a first-in-class protease-activated receptor-1 (PAR-1) antagonist designed to inhibit the formation of blood clots. PAR-1 is a receptor activated by thrombin, known to be a potent platelet activator. Vorapaxar inhibits thrombin-induced platelet aggregation by inhibiting PAR-1 receptors on platelets.
Data supporting the filing of this new drug application are from the 26,449 patient TRA 2°P - TIMI 50 trial, a randomized, double-blind, placebo-controlled study of vorapaxar used in addition to standard therapy including other antiplatelet agents. Patients included in the study had a history of myocardial infarction, ischemic stroke, or peripheral artery disease and had a median follow-up of 2.5 years.
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This news release 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 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’s 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. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2012 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).
Zontivity™ is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., USA
Source: Merck & Co., Inc.
Posted: January 2014
- FDA Approves Zontivity to Reduce the Risk of Heart Attacks and Stroke - May 8, 2014
- Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine - July 24, 2013