After twice delaying approval of the drug, the U.S. Food and Drug Administration (FDA) has now cleared Eliquis for the prevention of stroke and dangerous blood clots in patients diagnosed with non-valvular atrial fibrillation, the most common type of heart rhythm abnormality.
Eliquis, developed by Bristol-Myers Squibb and Pfizer, is the latest addition to a family of three next-generation blood thinner drugs approved by the FDA in the last two years; the others are Pradaxa and Xarelto.
FDA approval of Eliquis came after the drug’s approval in Japan and the European Union, and several months before the scheduled ruling set for March 17, 2013. The agency initially was expected to make the decision in March 2012, but requested more time to review new data.
By June 2012, the FDA had again postponed the drug’s approval as it awaited results from ARISTOTLE, a clinical study comparing the safety and effectiveness of Eliquis to warfarin, a more dated anticoagulant, in more than 18,000 patients with non-valvular atrial fibrillation.
New Drug, Familiar Risk
Eliquis, Pradaxa and Xarelto were all developed as alternatives to warfarin, which the FDA approved nearly 60 years ago. Although warfarin was once the go-to treatment for patients with atrial fibrillation not caused by a heart valve problem, its safe use requires regular blood monitoring by doctors.