US FDA panel recommends approval of Eli Lilly and Daiichi Sankyo's prasugrel
A US Food and Drug Administration expert panel has unanimously voted to approve Eli Lilly and Daiichi Sankyo's prasugrel for the treatment of patients with acute coronary syndromes managed with an artery-opening procedure known as percutaneous coronary intervention.
The Cardiovascular and Renal Drugs Advisory Committee voted nine to zero that the potential blockbuster antiplatelet agent, should be cleared for marketing as patient benefit outweighed the higher risk of bleeding.
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