FDA takes extra time to approve new blood-thinner

The Food and Drug Administration will take three more months to review the new drug against blood clots developed by Eli Lilly and Co.

The new medication known as prasugrel was developed for patients with acute coronary syndromes, which include heart attacks or unstable angina. Such patients are at higher risk of developing blood clots.

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In the event the FDA approves the drug, prasugrel would be able to compete against Plavix by Bristol-Myers Squibb Co. and Sanofi-Aventis.

Prasugrel (marketing name Effient) is a novel platelet inhibitor developed by Daiichi Sankyo Co. and produced by Ube and currently under clinical development in cooperation with Eli Lilly and Company for acute coronary syndromes planned for percutaneous coronary intervention (PCI). Prasugrel is a member of the thienopyridine class of ADP receptor inhibitors, like ticlopidine (trade name Ticlid) and clopidogrel (trade name Plavix). These agents are believed to reduce the aggregation ("clumping") of platelets by irreversibly binding to P2Y12 receptors.

As published in the New England Journal of Medicine's online edition, the TRITON-TIMI 38 study of 13,608 patients with acute coronary syndromes compared prasugrel against clopidogrel, both in combination with aspirin, and found that, as a more potent anti-platelet agent, prasugrel reduced the combined rate of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (12.1% for clopidogrel vs. 9.9% for prasugrel). These favorable results were obtained at the expense of increasing the rate of serious bleeding (1.4%, vs. 0.9% in the clopidogrel group) and fatal bleeding (0.4% vs. 0.1%). This resulted in an overall net clinical benefit in favour of prasugrel.

From the editorial in the NEJM, "In TRITON–TIMI 38, for each death from cardiovascular causes prevented by the use of prasugrel as compared with clopidogrel, approximately one additional episode of fatal bleeding was caused by prasugrel".

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