Bristol-Myers Squibb (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved ELIQUIS ® (apixaban) for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). ELIQUIS is a novel anticoagulant that has demonstrated risk reductions versus warfarin in three important outcomes of stroke, major bleeding and all-cause death. ELIQUIS is an oral direct Factor Xa inhibitor, part of a novel therapeutic class. This is the third approval for ELIQUIS for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, following approvals in the European Union and Canada.
“Today’s approval of ELIQUIS is the result of our shared vision with Pfizer to introduce a differentiated treatment option to reduce the burden of stroke in patients with nonvalvular atrial fibrillation,” said Charles Bancroft, executive vice president, Intercontinental Region and Japan, and chief financial officer, Bristol-Myers Squibb. “We are confident in the clinical profile of ELIQUIS and look forward to making this important medicine available to patients in Japan.”
“The approval in Japan marks the third regulatory approval for ELIQUIS within six weeks,” said John Young, president and managing director, Pfizer Primary Care Business Unit. “We are excited by this momentum and confident that our combined cardiovascular leadership and expertise with BMS will lead to a successful introduction of this important medicine to patients and physicians in Japan.”
The approval of ELIQUIS in Japan is supported by the pivotal Phase 3 trial, ARISTOTLE, which evaluated the safety and efficacy of ELIQUIS versus warfarin in 18,201 patients with NVAF, including 336 patients from Japan. Additionally, the safety and efficacy of ELIQUIS in Japanese patients were evaluated in a subanalysis of the ARISTOTLE study, which demonstrated results consistent with the overall study. The application for ELIQUIS for the prevention of ischemic stroke and systemic embolism was submitted in Japan on December 21, 2011.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV