This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Merck Statement On FDA Advisory Committee For Vorapaxar, Merck’s Investigational Antiplatelet Medicine

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.

About Vorapaxar

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.

About Merck

Today's Merck is a global healthcare 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 consumer care 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 healthcare 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 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.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 16,643.01 -11.76 -0.07%
S&P 500 1,988.87 +1.21 0.06%
NASDAQ 4,828.3250 +15.6170 0.32%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs