Orlando, Fla.—A new analysis of the HORIZONS-AMI trial found no increased stent thrombosis with drug-eluting stents (DES) compared with bare-metal stents (BMS)—both shortly after PCI and at one year. It also found that adjunct pharmacologic therapy influenced the risk of stent thrombosis, according to research presented Sunday during the i2 Summit at the American College of Cardiology’s 58th annual scientific session.
Daiichi Sankyo and Eli Lilly have confirmed that the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) will review prasugrel during a committee hearing on Feb. 3.
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After much anticipation, an FDA advisory panel today voted 9 to 0 to recommend prasugrel—a blood-thinner that could replace the blockbuster clopidogrel (Plavix, Bristol Myers Squibb and Sanofi-Aventis)—as a treatment for patients with acute coronary syndrome (ACS). The FDA usually, but not always, follows such recommendations.
Three months ago, the FDA said it would make a decision about
prasugrel, an oral antiplatelet agent, by Sept. 26. Late that Friday
afternoon, Daiichi Sankyo and Eli Lilly issued a statement saying the
FDA’s review was still ongoing.
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