FDA Grants New Indication For Pfizer/Bristol Anticoagulant

The FDA has authorized a new indication for apixaban (Eliquis), the anticoagulant drug produced by Bristol-Myers Squibb Bristol-Myers Squibb and Pfizer Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) in individuals who have undergone hip or knee replacement surgery. DVT can lead to the lifestyle-threatening condition of pulmonary embolism (PE). The DVT prophylaxis indication joins the previously approved indication of stroke prevention in sufferers who have nonvalvular atrial fibrillation.

In accordance to the organizations, approximately 719,000 total knee substitute surgeries and 332,000 hip replacement surgeries are performed each and every year in the US. The use of anticoagulants are suggested in these patients simply because they are at elevated danger for developing DVT and PE.

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

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

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