March 14th, 2014

Apixaban Gains Indication for DVT Prophylaxis After Knee and Hip Replacement Surgery

The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism in patients who have undergone hip or knee replacement surgery. The DVT prophylaxis indication joins the previously approved indication of stroke prevention in patients who have nonvalvular atrial fibrillation.

According to the companies, approximately 719,000 total knee replacement surgeries and 332,000 hip replacement surgeries are performed each year in the US. The use of anticoagulants is recommended in these patients because they are at elevated risk for developing DVT and PE.

The new indication is based on results of the ADVANCE clinical trial program in which apixaban was compared to enoxaparin in more than 11,000 patients.

Among the new oral anticoagulants only rivaroxaban (Xarelto, Johnson & Johnson) had been approved previously for DVT prophylaxis in orthopedic patients.




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