FDA adds DVT, PE to apixaban’s approval list

Candace Stuart | | Cardiovascular Business | Vascular & Endovascular

The FDA gave the green light to apixaban as a treatment for deep vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk of DVT and PE recurrence.

Apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) is a direct factor Xa inhibitor. It previously was approved in the U.S. to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and as a prophylaxis of DVT in patients who received hip or knee replacement surgery.

The drug had been approved in Europe for the prevention of DVT and PE in adults who have undergone elective hip or knee replacement surgery; for prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation with one or more risk factors; and most recently for the treatment of DVT and PE and the prevention of recurrent DVT and PE in adults.

The FDA based its approval on results from the AMPLIFY (Apixaban after the initial Management of Pulmonary emboLIsm and deep vein thrombosis with First-line therapY) and AMPLIFY-EXT trials. In AMPLIFY, apixaban was found to be comparable to standard care for efficacy with less major bleeding. A recent analysis of AMPLIFY-EXT data showed continuing treatment of either 2.5 mg and 5 mg dose apixaban reduced the risk of recurrent DVT and PE.

Candace Stuart, Contributor

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