Biotech Values

[DewDiligence]

FDA Panel Unanimously Recommends Prasugrel

[This is a clear-cut win for LLY and Daiichi Sankyo—the recommended restrictions in the label are even narrower than what LLY was prepared to concede with respect to age and weight.]

http://online.wsj.com/article/SB123369580096644823.html

›FEBRUARY 3, 2009, 5:42 P.M. ET
By JENNIFER CORBETT DOOREN

WASHINGTON -- A Food and Drug Administration panel Tuesday unanimously recommended the agency approve prasugrel, a proposed anticlotting drug being developed by Eli Lilly and Co. and Daiichi Sankyo Co., with warnings about bleeding risks.

Prasugrel is designed to keep blood platelets from sticking together to form dangerous blood clots that can cause heart attacks and strokes. If approved, prasugrel would initially be used in heart patients undergoing a procedure known as percutaneous coronary intervention to open clogged arteries. PCI is usually followed by the placement of a stent.

The main clinical trial involving more than 13,000 patients submitted to the FDA in support of prasugrel showed it was better than another drug, Plavix, at preventing life-threatening blood clots in heart patients, but it was also associated with a higher risk of dangerous bleeding in some patients. If approved, prasugrel would compete against Plavix, comarketed by Bristol-Myers Squibb Co. and Sanofi Aventis SA, which had more than $7 billion in sales in 2007 and was the second top-selling drug globally behind Pfizer Inc.'s Lipitor.

The panel said the prasugrel shouldn't be used in patients with a history of stroke and those who are undergoing open-heart surgery, but it stopped short of recommending additional restrictions such as limiting use of the drug to patients age 75 and older.

The panel said doctors should be told older patients and those who weigh less than 130 pounds have a higher risk of bleeding. The panel said doctors should be cautious about using prasugrel in that group, but said that bright lines shouldn't be drawn at limiting use to that patient population.

The panel's recommendation follows a generally positive review by FDA staff. Agency reviewers said they thought prasugrel should be approved but wanted advice about the type of warnings that should be placed on the drug's label.‹