BREAKING: FDA approves Lilly blood-thinner prasugrel

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Eli Lilly and Co. finally won approval today from U.S. regulators to sell prasugrel, its highly anticipated blood thinner, according to Bloomberg News.

The U.S. Food and Drug Administration approved prasugrel to prevent blood clots when patients come in to receive stents or other coronary devices. The drug will have the trade name Effient.

After waiting a year longer than expected, Indianapolis-based Lilly has suffered a setback that likely will make the drug much less lucrative than analysts once anticipated.

Most analysts predict prasugrel sales will reach $900 million to $1.1 billion by the end of 2011, when its main rival Plavix will become available in much cheaper generic versions. Two years ago, analysts’ sales predictions were as much as 70 percent higher than they are now.

Lilly will book half to two-thirds of prasugrel sales, with the rest going to its development partner, Japan-based Daiichi Sankyo Co. Ltd.

“Because of the time and the way things have worked out, it’s just not going to be the driver that people thought it was going to be,” said Les Funtleyder, a health care analyst at Miller Tabak & Co. in New York. However, he added, “It’s still an important factor for Lilly, because it is a new drug that will generate revenue.”

Lilly needs new revenue fast because its bestseller, the antipsychotic Zyprexa, will face generic competition at the end of 2011. Lilly gets $4.7 billion a year, or 23 percent of its sales.

Prasugrel has been on sale in some European countries, under the name Efient, since early April. Lilly will report sales results of the drug on July 22.

Lilly tested prasugrel head-to-head against Plavix in a clinical trial. Prasugrel proved 19 percent more effective at preventing heart attacks and strokes, but it also caused a higher rate of serious bleeding, including more fatalities.

Plavix, made by New York-based Bristol-Myers Squibb Co. and France-based Sanofi Aventis SA, was second-best-selling drug in the world last year, racking up $9.4 billion.

Those double-edged results appeared to cause conflicting views among FDA staff members. In October, The Pink Sheet, a trade publication, reported that prausgrel had sparked a “serious internal disagreement” over whether to approve it.

Things seemed to tip in prasugrel’s favor in February when the FDA’s advisory committee of cardiology experts voted 9-0 to approve the drug. But then news surfaced that the FDA had removed a prasugrel critic from the panel after Lilly asked it to do so.

Consumer groups howled and asked for further delay so the incident could be investigated. They got no official word, but the approval process dragged on for another five months.


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