Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) said Monday that the U.S. Food and Drug Administration issued a Complete Response Letter regarding the New Drug Application for Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Following the news, shares of Bristol-Myers are falling over 4 percent in pre-market activity.
The letter requests additional information on data management and verification from the Aristotle trial. The FDA has not requested that the companies complete any new studies.
The drugmakers said they would work closely with the FDA on the appropriate next steps for the Eliquis application.
Eliquis is the approved trade name for apixaban in Europe and the proposed trade name in the U.S. It is not approved for the prevention of stroke or systemic embolism in patients with atrial fibrillation in any country.
In May 2011, Bristol-Myers Squibb and Pfizer announced the first regulatory approval for Eliquis in the European Union for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.
In February 2012, the companies announced that the FDA had extended the action date for the Eliquis NDA for prevention of stroke and systemic embolism in patients with atrial fibrillation by three months to June 28, based on a major amendment to the NDA.
Elliott Sigal, Executive Vice President and Chief Scientific Officer, Bristol-Myers Squibb, said today, "There is a significant unmet need to reduce the risk of stroke in patients with atrial fibrillation. We believe that the two large trials called ARISTOTLE and AVERROES have established the therapeutic profile for ELIQUIS and demonstrated a meaningful advance over the standard of care."
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 around 24,000 patients with atrial fibrillation, including patients who are expected or demonstrated to be unsuitable for vitamin K antagonist 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. This will include nine completed or ongoing, randomized, double-blind Phase 3 trials.
BMY, which closed at $35.36 on Friday, is losing 4.23 percent in pre-market activity.
PFE, which settled the previous session at $22.73, is falling 2.4 percent in pre-market trading.
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