Source: http://www.nytimes.com/2009/07/11/health/policy/11drug.html?_r=1&ref=healthF.D.A. Approves Eli Lilly Blood Thinner, With a Warning
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By THE ASSOCIATED PRESS
Published: July 10, 2009
WASHINGTON (AP) The Food and Drug Administration approved a highly anticipated blood thinner from Eli Lilly on Friday, though the drug must carry the agencys sternest warning because of its risk of causing bleeding.
The approval makes Lillys Effient the first real competition to the blood thinner Plavix, which is made by Sanofi-Aventis and Bristol-Myers Squibb and is the worlds second-best selling medication behind the cholesterol pill Lipitor.
The F.D.A. delayed its decision on Effient several times during an 18-month review as agency officials weighed the drugs benefits and risks.
A Lilly study of more than 13,000 patients found that Effient prevented more heart attacks than Plavix, but caused more internal bleeding.
The F.D.A. said Effient would carry a boxed warning to alert physicians to the risks of significant, sometimes fatal, bleeding. The boxed warning is reserved for issues that can cause serious injury or death.
Effient should not be taken by patients with a history of bleeding, stroke or who are undergoing an operation, the F.D.A. said.
Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug, said Dr. John Jenkins, director of new drugs for the F.D.A.
The drug offers an alternative treatment for preventing dangerous blood clots that can lead to heart attack or stroke, Dr. Jenkins said.
The boxed warning could curb sales, but not to a large extent, said Les Funtleyder, an analyst at Miller Tabak & Company, an institutional trading firm.
The F.D.A. has been a lot more liberal with black box warnings than it was in the past, and in a way the black box has lost some of the meaning it had when it was rare, Mr. Funtleyder said. But it still has the ability to somewhat limit sales.
Company studies showed 7 percent of patients taking Effient had nonfatal heart attacks, compared with 9.1 percent of patients taking Plavix. Despite lower rates of certain heart attacks, the actual rates of death for the drugs were similar.
Lilly, based in Indianapolis, developed Effient, known chemically as prasugrel, with the Daiichi Sankyo Company of Japan. They will share revenue.
Wall Street analysts said Effient sales could reach $1 billion annually, compared with $4.9 billion in sales for Plavix last year.
Like Plavix, Effient prevents blood platelets from sticking together and forming potentially dangerous clots. But while Plavix is approved for use in a wide range of patients, Effient is approved only for those undergoing angioplasty, a procedure in which an inflatable balloon is used to clear arteries clogged with plaque, which are often propped open with a stent.
Approval of Effient was considered crucial for Lilly because patents protecting its four best-selling drugs expire by 2013.
Stock in Lilly rose 32 cents, to $33.32 a share.