UPDATE 2-US FDA approves Lilly, Daiichi's blood thinner

Fri Jul 10, 2009 7:18pm EDT
 
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* Warning about bleeding risk may slow use -analysts

* FDA: companies must study cancer cases

* Lilly says will be "competitive" with Plavix

* Lilly shares close up 1 pct (Adds FDA and company comment, analyst reaction, background)

By Susan Heavey and Lisa Richwine

WASHINGTON, July 10 (Reuters) - U.S. health officials approved Eli Lilly and Co (LLY.N) and Daiichi Sankyo Co Ltd's (4568.T) blood thinner Effient after several delays, and called for the pill to carry a strong warning about bleeding risks.

The drug, a rival to Sanofi-Aventis SA (SASY.PA) and Bristol-Myers Squibb Co's (BMY.N) blockbuster drug Plavix, will include a "black box" warning about its potential for "significant, sometimes fatal, bleeding," the Food and Drug Administration said on Friday.

Both drugs aim to prevent dangerous blood clots that can cause heart attacks or strokes. Studies showed Effient was more effective at preventing heart problems than Plavix, but had a higher risk of bleeding.

"This is a drug that does some very good things - it's a very important part of the therapeutic landscape - and it has some things you've got to watch for," Dr. Robert Temple, head of the FDA office that reviews heart drugs, told reporters.

The approval of Effient, also known as prasugrel, comes after an 18-month review in which FDA officials twice postponed their decision.

Controversy flared last year when the FDA removed a cardiologist critical of the drug from one of its independent advisory panels after Lilly contacted the agency. The action sparked a congressional investigation.

Investors have been anxiously awaiting a verdict on the drug that some see reaching nearly $1 billion in sales by 2013 and $2 billion a decade from now.

Eli Lilly and Daiichi said they would launch the drug "in the coming weeks." While the companies noted the higher bleeding rate, they added in a statement that using the drug with appropriate patients "may help reduce this risk."

The approval initially sent Lilly shares more than 2 percent higher, but the stock gave up some ground to close up 1 percent at $33.32 on the New York Stock Exchange.

SLOW UPTAKE

"The black box is slightly disappointing. It means there will probably be slower uptake in the marketplace," said Natixis Bleichroeder analyst Jon LeCroy.  Continued...

 

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