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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowEli Lilly and Co. has won the unanimous backing of an advisory panel to introduce the first rival to the blood-thinner Plavix, the world’s No. 2-selling drug, Bloomberg News reported.
Advisers to the U.S. Food and Drug Administration voted 9-0 today in Silver Spring, Md., that Lilly’s blood thinner prasugrel 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 bound to follow advisory panel recommendations, but the agency usually does.
Prasugrel is Lilly’s best short-term hope to gin up 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.
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 the leading blood thinner, 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 has waited more than 13 months for the FDA to render a decision on prasugrel. The 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.
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