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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowA panel of government health experts yesterday said a highly anticipated Eli Lilly and Co. blood thinner marks a significant advance over older treatments and should be approved.
The nine members of the Food and Drug Administration’s cardiology advisory group unanimously voted in favor of the company’s anti-clotting drug prasugrel, saying it should be approved to reduce the risk of blood clots in heart patients who undergo procedures to keep their arteries propped open.
The FDA is not required to follow the advice of the panel, though it usually does.
Yesterday’s positive recommendation marks a remarkable turnaround for a drug that some analysts worried might be derailed by troublesome side effects, including internal bleeding.
Regulators have been reviewing prasugrel for more than a year and the FDA has twice missed its own deadlines for making a decision on the drug. The agency has not set a timetable for its final judgment.
Panelists yesterday said the drug’s ability to prevent potentially fatal heart attacks outweighed its risks of increased bleeding.
“I think it’s been demonstrated to be safe and effective in an appropriately selected group of patients,” said panelist Michael Domanski, a cardiologist with the National Institutes of Health.
If approved by the FDA, the drug would be the first rival to the blood-thinner Plavix, the world’s No. 2-selling drug.
Prasugrel is Lilly’s best short-term hope to generate more revenue before it loses patent protection in 2011 on its bestseller, the antipsychotic Zyprexa. At that point, Zyprexa’s $4.6 billion in annual sales will be stolen away by cheaper generic copies.
The prasugrel delays could cost Lilly. Cheaper generic copies of Plavix will hit the market in 2011, after the drug’s patents expire. Analysts think Lilly’s prasugrel would have a harder time gaining sales against cheaper alternatives.
Lilly has worked to develop prasugrel with Japan-based Daiichi Sankyo Co. Ltd. They will evenly split revenue from the drug, which analysts predict could reach $2.8 billion by 2013. If approved, prasugrel would be sold under the name Effient.
The FDA advisory panel puzzled over data from a huge head-to-head trial that pitted prasugrel against Plavix. That drug, marketed by New York-based Bristol-Myers Squibb Co. and France-based Sanofi Aventis SA, racked up 2007 sales of $8.5 billion.
In the clinical trial, called Triton, prasugrel proved 19-percent more effective at stopping blood clots and heart attacks, strokes and blood clots than Plavix. But it also caused higher rates of bleeding in 20 percent of the study’s 13,600 patients.
Lilly has requested approval to market prasugrel to a narrower slice of patients than take Plavix. Lilly’s clinical trials measured patients coming in to get stents or other significant procedures to prop open their arteries. Such patients account for at most 25 percent of Plavix’s market.
Right now, Lilly is also conducting another head-to-head trial against Plavix for other kinds of patients.
Lilly shares rose $1.42, or 3.8 percent, to close at $38.69 yesterday.
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