WASHINGTON (AP) — The Food and Drug Administration said Friday that it approved an anticlotting drug called Eliquis, developed by Bristol-Myers Squibb Co. and Pfizer Inc. It's a potential blockbuster in a new category of medicines to prevent strokes.
The agency previously rejected the drug twice, most recently in June, awaiting additional data from company trials.
The FDA cleared the pill for treating the most common type of irregular heartbeat, atrial fibrillation, in patients at risk for strokes or dangerous clots.
About a quarter of all people aged 40 and older develop atrial fibrillation, a condition in which the heart's two upper chambers contract irregularly and don't pump blood efficiently. This can persist for years or only happen occasionally. The condition increases the risk of a stroke fivefold.
For decades atrial fibrillation patients were treated with the blood thinner warfarin, sold under brands that included Coumadin. While warfarin is cheap, users must get frequent blood tests to ensure they're getting enough to prevent strokes but not too high a dose, which can cause dangerous internal bleeding.
In the last two years drug regulators in the U.S. and other countries have approved two other new anticlotting drugs for patients with atrial fibrillation: Pradaxa, from German drugmaker Boehringer Ingelheim, and Xarelto from partners Johnson & Johnson and Bayer Healthcare.