Pfizer and Bristol-Myers Squibb fail to win FDA approval for Eliquis

PRINCETON, N.J. & NEW YORK—Bristol-MyersSquibb Co. and Pfizer have announced that the U.S.Food and Drug Administration (FDA) recently issued a Complete ResponseLetter (CRL) regarding the New Drug Application (NDA) for Eliquis (apixaban)for the prevention of stroke and systemic embolism in patients with nonvalvularatrial fibrillation, failing to give them the approval they sought for the drug.

The CRL requests additional information on datamanagement and verification from the ARISTOTLE trial for Eliquis. The twocompanies report that they are not giving up on the drug yet and will "workclosely with the FDA on the appropriate next steps for the Eliquis application,"adding that the FDA has not requested that the companies complete any newstudies.

"There is a significant unmet need to reducethe risk of stroke in patients with atrial fibrillation," said Dr. ElliottSigal, executive vice president and chief scientific officer at Bristol-MyersSquibb. "We believe that the two large trials called ARISTOTLE andAVERROES have established the therapeutic profile for Eliquis and demonstrateda meaningful advance over the standard of care."

The companies are continuing to move the Eliquisapplication for stroke prevention in atrial fibrillation in markets outside ofthe United States, including the European Union and Japan, based on theARISTOTLE and AVERROES studies.

These studies evaluated Eliquis in approximately24,000 patients with atrial fibrillation, including patients who are expectedor demonstrated to be unsuitable for vitamin K antagonist therapy. Thecompanies say they "are committed to an ongoing clinical development programfor Eliquis, which is projected to include nearly 60,000 patients worldwideacross multiple indications and patient populations and includes a total ofnine completed or ongoing, randomized, double-blind Phase III trials."

In May 2011, Bristol-Myers Squibb and Pfizerannounced the first regulatory approval for Eliquis in the 27 countries of theEuropean Union for the prevention of venous thromboembolic events in adultpatients who have undergone elective hip or knee replacement surgery; however,the drug is not yet approved for the prevention of stroke or systemic embolismin patients with atrial fibrillation in any country. It was in 2007 that Pfizerand Bristol-Myers Squibb first entered into a worldwide collaboration todevelop and commercialize Eliquis, an investigational oral anticoagulantdiscovered by Bristol-Myers Squibb. This global alliance was formed to combineBristol-Myers Squibb's long-standing strengths in cardiovascular drugdevelopment and commercialization with Pfizer's global scale and expertise inthe field.