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

Amarin Announces FDA Acceptance Of Supplemental New Drug Application (sNDA) For Vascepa(R) For The Treatment Of Patients With High Triglycerides (>200 Mg/dL And <500 Mg/dL) With Mixed Dyslipidemia

BEDMINSTER, N.J. and DUBLIN, Ireland, April 23, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the Food and Drug Administration (FDA) has accepted its Supplemental New Drug Application (sNDA) seeking approval for the marketing and sale of Vascepa (R) (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ≥200 mg/dL and <500 mg/dL) with mixed dyslipidemia.  The acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review. The application will be subject to a standard review and has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013. The PDUFA date is the target date for the FDA to complete its review of the sNDA.

"We are very pleased that the FDA has accepted our sNDA submission for the ANCHOR indication, which supports the potential expansion of the Vascepa patient population to include adult patients on statin therapy with triglyceride levels ranging from 200 to 499 mg/dL and mixed dyslipidemia. We estimate that one in five, or nearly 40 million, U.S. adults have triglyceride levels ranging from 200 to 499 mg/dL," stated Joseph S. Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The ANCHOR study showed that Vascepa is unique in that it significantly lowered both triglycerides and LDL-cholesterol on top of optimized statin therapy and exhibited a safety and tolerability profile similar to placebo, unlike the clinical results of other triglyceride-lowering therapies.  If approved for the ANCHOR indication, Vascepa will be the only approved prescription omega 3 therapy for cardiovascular health management in this patient population (TG ≥200 mg/dL and <500 mg/dL with mixed dyslipidemia) and will represent the next generation of lipid management for potentially millions of patients."

1 of 3

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 16,351.38 +293.03 1.82%
S&P 500 1,948.86 +35.01 1.83%
NASDAQ 4,749.9790 +113.8740 2.46%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs