Lilly Blood Thinner Prasugrel Earns EU Approval
Mon, 02/23/2009 - 9:11am
By TOM MURPHY AP Business Writer INDIANAPOLIS (AP) — European Union regulators have approved the blood thinner prasugrel, drugmaker Eli Lilly & Co. announced Monday morning. The European Commission granted marketing authorization for prasugrel, which will be sold in Europe under the brand name Efient. Lilly spokeswoman Carole Copeland said the drug will be launched "in the coming weeks," with a separate rollout in each country. Indianapolis-based Lilly developed prasugrel with Japanese drugmaker Daiichi Sankyo Co., and the two companies will share revenue. The drug is designed to prevent dangerous blood clots from forming in patients with acute heart problems, like heart attacks, who have had stents implanted in their arteries .Prasugrel will compete with the blockbuster blood thinner Plavix, which is marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis. Plavix had U.S. sales of $4.9 billion last year and was the world's second best-selling prescription medicine. Some analysts predict that prasugrel, which will be sold as Effient if approved in the United States, could surpass $1 billion in annual sales within a few years. Lilly and Daiichi Sankyo are still waiting for approval from U.S. regulators. But prasugrel won a strong endorsement earlier this month, when a nine-member Food and Drug Administration cardiology panel voted unanimously in favor of the drug's approval. The FDA still must decide whether to approve it. The agency has twice delayed making a decision on the drug and is not required to follow the advice of the panel, though it usually does. Copeland said Lilly officials are still talking with U.S. regulators, but she had no time frame for that approval. "We're still confident in that submission and working diligently with them as they continue their review," she said.