The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Bristol-Myers Squibb Company and Pfizer 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.

“There is a significant unmet need to reduce the risk of stroke in patients with atrial fibrillation,” said Elliott Sigal, MD, PhD, 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 Eliquis application for stroke prevention in atrial fibrillation in markets outside of the US, including the European Union and Japan, based on the ARISTOTLE and AVERROES studies. These studies evaluated Eliquis in approximately 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 III trials.

Eliquis is the approved trade name for apixaban in Europe and the proposed trade name in the US. 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 (VTE) 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, 2012 based on a major amendment to the NDA.

In addition to stroke prevention in patients with atrial fibrillation and the prevention of VTE in patients who have undergone total hip or total knee replacement surgery, Eliquis is being investigated in phase III trials for the treatment of VTE.

In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize Eliquis, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

Pfizer strives to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Its diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products.