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 Enrollment Of The REDUCE-IT Cardiovascular Outcomes Study Surpasses 6,000 Patients

BEDMINSTER, N.J., and DUBLIN, Ireland, Sept. 25, 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 number of patients enrolled in the company's REDUCE-IT cardiovascular outcomes study of Vascepa ® (icosapent ethyl) capsules has surpassed 6,000.   

The REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial) study is a multinational, prospective, randomized, double-blind, placebo-controlled, parallel-group study taking place at over 400 clinical sites in 11 countries to evaluate the effectiveness and safety of Vascepa ® (icosapent ethyl) capsules, as an adjunct to optimized statin therapy, in reducing the incidence of first major cardiovascular events in a patient population at high risk for such events. The control arm of the study consists of patients on optimized statin therapy plus placebo. The active arm of the study consists of patients on optimized statin therapy plus Vascepa 4g/day. The high-risk patient population in REDUCE-IT has both a mean and median baseline triglyceride (TG) level over 200 mg/dL, a level substantially above those from recently conducted outcomes trials of other prescription lipid modifying therapies. Furthermore, Amarin has taken steps to ensure that the final baseline TG levels remain above 200 mg/dL. In addition, all patients enrolled in the study have either documented cardiovascular disease (CVD) or are at high-risk for CVD.

The REDUCE-IT study is being conducted under Amarin's previously announced Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). An SPA agreement is an agreement with the FDA that the Phase 3 trial protocol design, clinical endpoints, and planned statistical analyses are acceptable to support regulatory approval. An SPA agreement is generally considered binding upon the FDA unless public health concerns unrecognized at the time of protocol assessment are evident.

"Reaching the 6,000 patient mark in the REDUCE-IT trial represents significant progress toward full enrollment and another significant highlight for Amarin in 2013," said Joseph Zakrzewski, Amarin's Chairman and CEO. "The results of REDUCE-IT may enable us to seek additional indications for Vascepa including cardiovascular risk reduction, which would represent a patient population estimated to be almost twice that of the combined indications studied in the MARINE and ANCHOR trials or approximately 70 million adults in the United States alone."

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

DOW 18,068.10 -58.02 -0.32%
S&P 500 2,115.69 -5.10 -0.24%
NASDAQ 5,087.4110 -10.5650 -0.21%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs