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FDA approves Eliquis for treatment of DVT, PE

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The FDA has approved a supplemental new drug application for apixaban, an oral selective Factor Xa inhibitor, for the treatment of deep vein thrombosis and pulmonary embolism, as well as for reduction of the risk for recurrence of those conditions after initial therapy.

According to a press release from Bristol-Myers Squibb and Pfizer, the approval follows results from the AMPLIFY and AMPLIFY-EXT trials. In the AMPLIFY trial, a regimen of apixaban (Eliquis) consisting of 10 mg twice daily for 1 week followed by 5 mg twice daily for 6 months (n=2,609) was comparable to standard care (n=2,635) in the incidence of a composite primary endpoint of recurring, symptomatic venous thromboembolism or VTE-related mortality (2.3% vs. 2.7%; RR=0.84; 95% CI, 0.6-1.18). Eliquis was also superior to standard care in incidence of the primary safety endpoint of major bleeding (0.6% vs. 1.8%; RR=0.31; 95% CI, 0.17-0.55), as well as for a secondary safety endpoint of non-major bleeding (3.9% of cases vs. 8%).

Prescribing information for the drug will include boxed warnings indicating increased risk for thrombotic events after premature discontinuation of Eliquis, as well as for increased risk of epidural or spinal hematoma among those using the drug while undergoing spinal puncture or epidural anesthesia, according to the release.

Eliquis is also indicated to reduce risk for stroke and systemic embolism among patients with nonvalvular atrial fibrillation, and for prevention of DVT among recipients of hip or knee replacement surgery.

“We are pleased that Eliquis is now available as an effective treatment option for DVT and PE,” Douglas Manion, MD, head of specialty development for Bristol-Myers Squibb, said in the press release. “Eliquis offers oral dosing, no routine coagulation testing and does not require the use of a parenteral anticoagulant or bridging during initiation.”