FDA responds letter for apixaban’s new drug application


Bristol-Myers Squibb and Pfizer announced that the FDA has issued a complete response letter regarding the new drug application for apixaban (Eliquis) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

The complete response letter 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 apixaban 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. “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 apixaban application for stroke prevention in atrial fibrillation in markets outside of the USA, including the European Union and Japan, based on the ARISTOTLE and AVERROES studies. These studies evaluated apixaban in approximately 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 programme for apixaban, 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, randomised, double-blind phase 3 trials.

About Eliquis

Eliquis is the approved trade name for apixaban in Europe and the proposed trade name in the USA. Eliquis 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 27 countries of 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 new drug application for prevention of stroke and systemic embolism in patients with atrial fibrillation by three months to 28 June 2012 based on a major amendment to the new drug application.