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Pfizer and Bristol-Myers Squibb fail to win FDA approval for Eliquis
PRINCETON, N.J. & NEW YORK—Bristol-Myers Squibb Co. and Pfizer have announced that the U.S. Food and Drug Administration (FDA) recently 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 nonvalvular atrial fibrillation, failing to give them the approval they sought for the drug.
The CRL requests additional information on data management and verification from the ARISTOTLE trial for Eliquis. The two companies report that they are not giving up on the drug yet and will "work closely with the FDA on the appropriate next steps for the Eliquis application," adding that 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 Dr. Elliott Sigal, executive vice president and chief scientific officer at 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 are continuing to move the Eliquis application for stroke prevention in atrial fibrillation in markets outside of the United States, 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 therapy. The companies say they "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."
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; however, the drug is not yet approved for the prevention of stroke or systemic embolism in patients with atrial fibrillation in any country. It was in 2007 that Pfizer and Bristol-Myers Squibb first entered into a worldwide collaboration to develop and commercialize Eliquis, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance was formed to combine Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer's global scale and expertise in the field.