August 21st, 2014

FDA Grants Apixaban Expanded Indication for Venous Thromboembolism

The FDA today approved an expanded indication for the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy. The supplemental new drug application was based on findings from the previously published AMPLIFY and AMPLIFY-EXT studies.

All three of the new oral anticoagulants — dabigatran (Pradaxa, Boehringer Ingelheim), rivaroxaban (Xarelto), and apixaban – have now gained both the VTE indication as well as the indication for stroke prevention in patients with nonvalvular atrial fibrillation (SPAF). Rivaroxaban and apixaban are also approved for DVT prophylaxis following hip- or knee-replacement surgery.

Both apixaban and rivaroxaban were studied using a single-drug approach for acute use in the hospital and for continued use afterwards. By contrast, dabigatran was studied in patients after they had received parenteral anticoagulants and is indicated for use following treatment with a parenteral anticoagulant for 5 to 10 days.



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