UPDATE 1-US approves Lilly, Daiichi's Effient blood thinner

By Susan Heavey WASHINGTON, July 10 (Reuters) - U.S. health regulators have approved Eli Lilly and Co and Daiichi Sankyo Co Ltd's long-awaited blood thinner, Effient, the Food and Drug Administration said on Friday. The drug, a rival to Sanofi-Aventis SA and Bristol-Myers Squibb Co's blockbuster drug, Plavix, will include a "black box" warning about its potential for "significant, sometimes fatal, bleeding," the FDA said. Also known as prasugrel, Effient should not be used by patients with certain bleeding, a history of stroke or an urgent need for surgery, the agency said in a statement. Effient aims to prevent dangerous blood clots that can cause heart attacks or strokes with heart surgery, but "physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug," said Dr. John Jenkins, director of the FDA's office of new drugs. The drug approval came after an 18 month review in which FDA officials twice postponed their decision. Controversy surrounded an independent FDA advisory panel in which one critical cardiologist was removed after Lilly contacted the agency. Investors have been anxiously awaiting a verdict on the drug that some see reaching $2 billion in sales in about 10 years. "The black box is slightly disappointing. It means there will probably be slower uptake in the marketplace," said Natixis Bleichroeder analyst Jon LeCroy. The approval initially sent Lilly shares up as much as 2 percent before retreating to closed up nearly 1 percent at $33.32 on the New York Stock Exchange. Eli Lilly spokeswoman Tammy Hull confirmed the agency had approved the drug, but declined to comment further until details about the drug's label were available. (Additional reporting by Lisa Richwine in Washington and Deena Beasley in Los Angeles, editing by Matt Daily and Andre Grenon ) Keywords: ELILILLY EFFIENT/ ([e-mail]; [phone]) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved.

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