CardioExchange Archive

December 28th, 2012

FDA Approves Eliquis (Apixaban) for Stroke Prevention in AF

Larry Husten, PHD

The FDA has finally approved apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, 2013. Eliquis is the latest member […]

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September 27th, 2012

FDA Sets New Decision Date for Eliquis (Apixaban)

Larry Husten, PHD

The FDA  will decide the fate of apixaban (Eliquis) by March 17, 2013. The new Prescription Drug User Fee Act (PDUFA) goal date was announced yesterday by the drug’s manufacturers, Pfizer and Bristol-Myers Squibb. The new drug application (NDA) for apixaban for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was highly praised when […]

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September 21st, 2012

Apixaban (Eliquis) For Atrial Fibrillation Gets Positive European Recommendation

Larry Husten, PHD

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval for apixaban (Eliquis, Pfizer and BristolMyers Squibb) for atrial fibrillation. The drug is already approved in Europe for the prevention of venous thromboembolic events following hip or knee replacement surgery. The drug has not yet been approved in the United States. Here is the CHMP-proposed indication for the […]

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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 […]

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March 1st, 2012

Decision on Apixaban (Eliquis) Pushed Back By 3 Months

Larry Husten, PHD

Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers Squibb announced on Wednesday evening that the FDA had extended by 3 months the action date for the new drug application (NDA) for the highly anticipated oral anticoagulant apixaban (Eliquis). The application is for their important indication of stroke prevention in atrial fibrillation. The […]

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