TRENTON, N.J. (AP) — Regulators in Japan have approved sales of an anticlotting drug called Eliquis, developed by Bristol-Myers Squibb Co. and Pfizer Inc., that's a potential blockbuster in a new category of medicines to prevent strokes and heart attacks. But that's only if it can win U.S. approval, as two rival drugs have done.
Pfizer and Bristol-Myers said Wednesday that Japan approved use of Eliquis for treating the most common type of irregular heartbeat, atrial fibrillation, in patients at risk for strokes or dangerous clots called systemic embolisms. Already approved for sale in Canada and the European Union, Eliquis has twice been rejected by the U.S. Food and Drug Administration.
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. It increases the risk of a stroke fivefold, and strokes caused by atrial fibrillation are more severe than other strokes, with half of patients who suffer them dying within a year if not treated.
For decades, atrial fibrillation patients were treated with the blood thinner warfarin, sold under brands including Coumadin. While warfarin is very 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 new anticlotting drugs for patients with atrial fibrillation and other conditions: Pradaxa, from German drugmaker Boehringer Ingelheim, and Xarelto, from partners Johnson & Johnson and Bayer Healthcare.
Some analysts have said Eliquis, known chemically as apixaban, is the best of the three new drugs, but Pradaxa and Xarelto got a big head start in building U.S. market share. That means that if Eliquis is approved by the FDA, Pfizer and Bristol-Myers will have a tough job persuading doctors and patients who already have switched from warfarin to Pradaxa or Xarelto to again switch medication.