U.S. panel backs Lilly, Daiichi anti-clotting drug
04 Feb 2009 00:14:48 GMT Source: Reuters
(Adds comments by panel member, analyst, Lilly) By Lisa Richwine SILVER SPRING, Md., Feb 3 (Reuters) - Eli Lilly and Co <LLY.N> and Daiichi Sankyo Co Ltd <4568.T> won unanimous support from a U.S. panel on Tuesday for a new blood thinner that would compete with the world's second best selling drug. The advisory panel voted 9-0 to urge the Food and Drug Administration (FDA) to approve prasugrel, a drug considered the most important product in Lilly's pipeline. The FDA usually approves drugs endorsed by advisory panels. Prasugrel would offer an alternative for some patients to Plavix, now sold by Bristol-Myers Squibb Co <BMY.N> and Sanofi-Aventis SA <SASY.PA> with more than $7 billion in 2007 global sales. Both drugs prevent dangerous blood clots in heart patients. In a Lilly and Daiichi study, prasugrel prevented more cardiovascular-related deaths and heart attacks than Plavix. But it also increased the chances of serious bleeding that can be fatal. The outside experts on the advisory panel said prasugrel's benefits justified the bleeding risk in certain cases. Panelists backed some measures to minimize side effects. Prasugrel was "demonstrated safe and effective in appropriately selected patients," said panel member Dr. Michael Domanski, a cardiologist at the National Heart, Lung and Blood Institute. BMO Capital Markets analyst Robert Hazlett said the panel review was smoother than expected. Analysts had previously voiced concern that the FDA would require strong warnings or restrictions that would dampen sales. "In general, the potential pitfalls didn't really manifest themselves. The committee seemed comfortable with the risks and the benefits of the therapy," Hazlett said. He estimated prasugrel sales would approach $1 billion by 2015. Others projected lower sales given the bleeding risks and competition from cheaper generic copies of Plavix expected in 2011. "I think the FDA will approve (prasugrel) with a very tight label restricting it to a very specific population," said Les Funtleyder, analyst for Miller Tabak & Co. He forecast sales "probably in the couple hundred millions" of dollars annually. FDA reviewers estimated that 21 heart attacks and three cardiovascular-related deaths would be prevented for every 1,000 patients treated with prasugrel instead of Plavix. The trade-off would be two deaths from bleeding and three nonfatal major bleeding episodes, FDA reviewers said. Panel members said prasugrel's prescribing instructions should discourage use in patients who have had a stroke. They voiced mixed views on other possible limits, such as using a lower dose for the elderly. The advisers did not support a strong warning about cases of cancer seen more commonly in prasugrel patients, saying there was no evidence the drug played any role. Many said it would suffice to mention the cancers on the drug label while the manufacturers study the issue further. Lilly Vice President Anthony Ware said the company agreed "it's important we get this drug to the right patients" and welcomed the panel's endorsement as a positive step. The companies are seeking FDA approval to market prasugrel under the brand name Effient for patients having chest pain or a heart attack and undergoing angioplasty to clear an artery. Plavix is approved for a larger group of patients. The companies have been waiting for more than a year for the FDA to rule. The agency has twice delayed its verdict on the drug and has not said when it will make a final decision. Lilly shares closed up 3.8 percent at $38.69 on the New York Stock Exchange. (Reporting by Lisa Richwine and Bill Berkrot; Editing by Andre Grenon, Phil Berlowitz)
