logo
Share SHARE
FONT-SIZE Plus   Neg

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

Bristol-Myers Squibb Co. (BMY) and Pfizer (PFE) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Taxi-hailing company Uber and its rival Careem has suspended their services in Abu Dhabi, the capital of the United Arab Emirates, since Saturday, reports said. Uber said the move was temporary, and did not explain the reason for suspension of services. Even after two years of thoroughly searching across the Indian Ocean, using modern technologies and devices, there is no clue about the Malaysian airline that vanished on March 8, 2014. Internet access is growing worldwide, but there is still a long way to go before the entire world is completely wired, a study from the Pew Research Center has found. The study also noted that men have greater access to the Internet than women in many nations.
comments powered by Disqus
Follow RTT