FDA approves apixaban

FDA approves apixaban

Jan 2, 2013
By: From staff reports
Formulary News Capsule

FDA announced recently it approved apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Atrial fibrillation affects about 5.8 million people in the United States and leads to 5 times greater risk of stroke. Atrial fibrillations attribute to 15% of strokes in the United States, and those with atrial fibrillation have a 5 times greater risk of stroke, according to a Bristol-Myers Squibb press release.

"The approval of Eliquis offers patients with nonvalvular atrial fibrillation a novel treatment option for reducing the risk of stroke," said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb, in the release. "Eliquis is the result of leading scientific innovation and the shared vision of our alliance to introduce a new oral anticoagulant for patients with nonvalvular atrial fibrillation in the United States."

The Eliquis clinical trial program is the largest completed clinical development program of its kind, and it included 2 landmark phase 3 studies in patients with nonvalvular atrial fibrillation and at least 1 additional risk factor for stroke. One study examined Eliquis versus warfarin in 18,201 patients with nonvalvular atrial fibrillation who were suitable for warfarin therapy, and another study compared Eliquis versus aspirin in 5,598 patients with nonvalvular atrial fibrillation who were considered unsuitable for treatment with warfarin, the release stated.

The box warning for Eliquis says patients who discontinue treatment are at an increased risk of thrombotic events. During the trials, patients with nonvalvular atrial fibrillation had an increased rate of stroke after discontinuing Eliquis. It is strongly advised that another anticoagulant be taken if anticoagulation treatment with Eliquis is discontinued.

"With a population that is living longer, the prevalence of nonvalvular atrial fibrillation is increasing, but many patients are still not being managed effectively with warfarin," said Christopher Granger, MD, professor of medicine, Duke Clinical Research Institute, Duke University Medical Center, Durham, N.C., and lead investigator of one of the studies, said in a press release. "Eliquis represents a significant advance over warfarin for healthcare professionals to reduce the risk of stroke in patients with nonvalvular atrial fibrillation."

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