FDA Expands Eliquis Indication to Treat Venous Thromboembolism

Bristol-Myers Squibb Co and Pfizer, Inc, today announced the FDA has expanded the use of the anticoagulant apixaban (Eliquis) to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), which are blood clots that form in the legs and lungs and affect approximately 900,000 Americans every year.

In a press release, Douglas Manion, MD, Head of Specialty Development for Bristol-Myers Squibb, noted the drug “offers oral dosing, no routine coagulation testing, and does not require the use of a parenteral anticoagulant or bridging during initiation.”

“DVT, which may lead to PE, can be a serious medical condition, with PE requiring immediate medical attention for treatment,” said Steve Romano, senior vice president and head of the Medicines Development Group for Global Innovative Pharmaceuticals at Pfizer. “Once a venous thromboembolism (VTE) has occurred, approximately 33% of patients are at risk of a recurrence within 10 years.”

With its expanded approval, Eliquis is now indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, prevent DVT in patients who have undergone hip or knee replacement surgery, treat DVT and PE, and reduce the risk of recurrent DVT and PE following initial therapy.

According to Bristol-Myers Squibb and Pfizer, the drug’s new indications are based on data from the global AMPLIFY and AMPLIFY-EXT studies.

In the AMPLIFY trial, Eliquis 10 mg administered twice daily for 1 week, followed by 5 mg twice daily for 6 months, demonstrated efficacy comparable to the standard of care—consisting of enoxaparin treatment for at least 5 days overlapped by warfarin therapy—in treating DVT and PE patients for recurrent, symptomatic VTE or VTE-related death.

The anticoagulant also demonstrated superiority in the safety endpoints of major bleeding and clinically relevant nonmajor bleeding, the rates of which were fewer in patients treated with Eliquis compared to those treated with enoxaparin and warfarin.

In AMPLIFY, the discontinuation rate due to bleeding events was 0.7% in the Eliquis-treated patients, compared to 1.7% in enoxaparin/warfarin-treated patients.

Because Eliquis increases the risk of bleeding and can cause serious and potentially fatal bleeding, the drug’s full Prescribing Information includes warnings for the increased risk of thrombotic events in patients who prematurely discontinue the drug, as well as for the increased risk of epidural or spinal hematoma, which may cause long-term or permanent paralysis in those taking Eliquis and undergoing spinal epidural anesthesia or spinal puncture.