CardioExchange Archive

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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February 28th, 2012

FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients

Larry Husten, PHD

The FDA has granted a priority review for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) in combination with standard therapy to reduce the risk for cardiovascular events in acute coronary syndrome (ACS) patients. The news was announced by Bayer and Johnson & Johnson. The FDA will now be required to respond within 6 months, instead of […]

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