Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Bristol-Myers Squibb, Pfizer Get Complete Response Letter For ELIQUIS

RELATED NEWS
Trade BMY now with 

Bristol-Myers Squibb Co. (BMY: Quote) and Pfizer (PFE: Quote) said the U.S. Food and Drug Administration or FDA has issued a Complete Response Letter relating to the New Drug Application or NDA forELIQUIS for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The Complete Response Letter requests additional information on data management and verification from the ARISTOTLE trial. Bristol-Myers Squibb and Pfizer would work closely with the FDA on the appropriate next steps for the ELIQUIS application. The FDA has not requested that the companies complete any new studies.

"There is a significant unmet need to reduce the risk of stroke in patients with atrial fibrillation," said Elliott Sigal, Executive Vice President and Chief Scientific Officer, Bristol-Myers Squibb. The companies continue to progress the ELIQUIS application for stroke prevention in atrial fibrillation in markets outside of the U.S., including the European Union and Japan, based on the ARISTOTLE and AVERROES studies.

The companies are committed to an ongoing clinical development program for ELIQUIS, which is estimated to comprise nearly 60,000 patients globally across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind Phase 3 trials.

Register
To receive FREE breaking news email alerts for Bristol-Myers Squibb Co. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Colorado based doctor Dilip Joseph, who was kidnapped by the Taliban discusses his ordeal in detail in a book published by Amazon on Tuesday. Extending the rebound seen over the course of the previous session, stocks moved sharply higher during trading on Friday. The gains on the day partly offset the recent sell-off on Wall Street, although the major averages remain well off their mid-September highs. While the Ebola outbreak in the U.S. has thus far been limited to just three people, the results of a new CBS News poll suggest that news of the disease has contributed to a sharp drop in public confidence in the Centers for Disease Control and Prevention.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.