Bristol-Myers Squibb Company (BMY)-Pfizer Inc. (PFE) Anticlot Drug Gets Key EU Approval
11/21/2012 7:27:44 AM
European health regulators on Tuesday approved an eagerly anticipated blood thinner developed by Bristol-Myers Squibb Co and Pfizer Inc for preventing strokes and blood clots in patients with an irregular heartbeat known as atrial fibrillation, the companies said. The drug Eliquis, also known as apixaban, is widely considered one of the most important new products for the two U.S. drugmakers, with multibillion-dollar annual sales potential. The European approval was expected after an advisory panel this year recommended it for atrial fibrillation. "It's not unexpected, but it's positive to finally get an afib approval under the belt for Eliquis," said MKM Partners analyst Jon Lecroy, who sees annual sales reaching $2 billion by about 2017. "We're looking for a March approval or earlier in the U.S. for the same indication," he added. The U.S. Food and Drug Administration is expected to decide on the proposed use of the drug in the world's biggest market by March 17, after delaying a decision in June to review more information from clinical trials. The European Commission approval marks the first regulatory approval for Eliquis for stroke prevention in atrial fibrillation patients in any market, the companies said.