U.S. regulatory staff recommended Eli Lilly and Co's and Daiichi Sankyo Co Ltd's anti-clotting drug prasugrel for approval on Jan 30 2009.
Prasugrel, which the companies plan to market under the name Effient, should be allowed on the U.S. market to reduce heart attacks in patients with acute coronary syndrome who are managed through angioplasty. [1]
Rival Plavix took in $4.92 billion in U.S. 2008 sales. Data from a 12-month study reviewed by FDA showed that for every 24 serious heart problems the drug prevented, it caused 10 bleeding side effects. Overall, reviewers concluded that prasugrel was associated with three fewer heart-related deaths than Plavix. [2] However, the data showed 27 cases of cancer in prasugrel patients compared to 19 in Plavix. [1]
[1]UPDATE 2-US FDA staff backs Lilly, Daiichi anti-clot drug Reuters Fri Jan 30, 2009 11:14am EST [2]FDA: Eli Lilly blood thinner has clear benefits Associated Press, Fri Jan 30, 2009
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