(By Balaseshan) Bristol Myers Squibb Co.'s (NYSE:BMY) and Pfizer Inc.'s (NYSE:PFE) blood clot preventer has been delayed for approval by the FDA as the agency seeks additional information. Following the news, shares of BMY fell 4.55% and PFE stock slid 2.31% in premarket.
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ELIQUIS (apixaban) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
The CRL requests additional information on data management and verification from the ARISTOTLE trial. Bristol-Myers Squibb and Pfizer will 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. FDA and the companies are committed to working expeditiously to address the outstanding questions and move the application forward.
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.
These studies evaluated ELIQUIS in about 24,000 patients with atrial fibrillation, including patients who are expected or demonstrated to be unsuitable for vitamin K antagonist (VKA) therapy.
The companies are committed to an ongoing clinical development program for ELIQUIS, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind Phase 3 trials.
BMY closed Friday's regular session up 1.64% at $35.36, while PFE ended up 0.55% at $22.73.