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
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