FDA Once Again Delays Approval of Apixaban (Eliquis)

June 25th, 2012

FDA Once Again Delays Approval of Apixaban (Eliquis)

Larry Husten, PHD

The FDA has once again delayed approval of apixaban (Eliquis), the much-anticipated oral anticoagulant. Bristol-Myers Squibb and Pfizer announced today that it had received a a Complete Response Letter (CRL) to the New Drug Application (NDA) for the drug for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

The two companies reported that the FDA had asked for “additional information on data management and verification from the ARISTOTLE trial.” No new trials were requested by the FDA, according to the companies, who said they “will work closely with the FDA on the appropriate next steps” for the NDA.

Following the widely praised publication and presentation of ARISTOTLE, it was widely anticipated that apixaban would sail through the FDA approval process. This view gained early confirmation when the FDA granted priority review for the NDA last November, but the picture grew cloudier earlier this year when the FDA extended the action date by three months.

Wall Street analyst Tim Anderson speculated that apixaban might still gain FDA approval in 2012, though firm predictions are difficult since Bristol-Myers Squibb and Pfizer have not released details about the questions raised by the FDA in the CRL.

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June 25th, 2012