logo
Share SHARE
FONT-SIZE Plus   Neg

Bristol-Myers Squibb And Pfizer Obtain EU Approval For Eliquis

Pfizer Inc. (PFE) and Bristol-Myers Squibb Co. (BMY) announced Tuesday that the European Commission has approved Eliquis or apixaban for prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation or NVAF with one or more risk factors.

The company said that Eliquis is the only oral anticoagulant that has demonstrated superior risk reduction versus warfarin in the three important outcomes of stroke and systemic embolism, major bleeding, and all-cause mortality.

Eliquis is an oral direct Factor Xa inhibitor, part of a novel therapeutic class. It is the first regulatory approval in any market for Eliquis for stroke prevention in patients with nonvalvular atrial fibrillation, the company said.

The marketing authorization for Eliquis is supported by the pivotal Phase 3 trials Aristotle and Averroes, which evaluated approximately 24,000 patients with NVAF in the largest completed clinical trial program conducted to date in this patient population.

Atrial fibrillation is the most common cardiac arrhythmia (irregular heart beat). It is estimated that approximately 6 million individuals in Europe have atrial fibrillation. The lifetime risk of developing atrial fibrillation is estimated to be approximately 25% for individuals 40 years of age or older.

In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize Eliquis, an investigational oral anticoagulant discovered by Bristol-Myers Squibb.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Alteryx, Inc., a provider of self-service data analytics software, is the latest tech company to go public in March. Alteryx said it has priced its IPO of 9 million shares of its Class A common stock at $14 per share, at the top end of its range of $12 to $14 per share. Dunkin' Donuts is bidding adieu to one of its frozen coffee beverages this summer. However, loyal fans of the decades-old menu staple have not taken kindly to the news. The coffee chain said it will discontinue its popular Coffee Coolatta beverage this summer and instead, introduce the new Frozen Dunkin' Coffee, made with coffee extract, sugar and milk. Canadian pipeline operator Enbridge Inc. said it will cut about 1,000 jobs, or six percent of its workforce, following the completion of its acquisition of Houston-based Spectra Energy Corp. The job cuts will take place across the merged company.
comments powered by Disqus
Follow RTT