FDA to review prasugrel for acute coronary syndromes
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Daiichi Sankyo Company, Limited and Eli Lilly and Company has confirmed that the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) will review prasugrel during an advisory committee hearing on February 3, 2009.
Prasugrel is an investigational antiplatelet agent for the treatment of patients with acute coronary syndromes (ACS) who are being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI), which is usually followed by the placement of a stent to help keep the artery open.
Advisory committees provide the FDA with independent advice from outside medical experts during the review process. The companies will have further discussions with the FDA in preparation for the Advisory Committee Meeting.
“We welcome the opportunity to discuss any and all of the prasugrel data with the advisory committee and the agency, just as we have throughout the ongoing review,” said John Alexander M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited.
“We have full confidence in the data submitted to the FDA and the overall benefit-risk profile of prasugrel, and we look forward to this next step in potentially bringing an important new alternative to the oral antiplatelet market,” said J. Anthony Ware, M.D., Lilly vice president and cardiovascular/acute care platform leader for prasugrel.
Acute coronary syndromes (ACS), which is comprised of heart attacks and unstable angina (chest pain), affects more than 1.4 million people in the United States annually.(i) Coronary heart disease, which can result in ACS, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(ii) Coronary artery disease occurs when the arteries become narrowed or clogged by cholesterol and fat deposits and cannot supply enough blood to the heart. In some cases, a blood clot may partially or totally block the blood supply to the heart resulting in ACS.(iii) Many ACS patients are managed with PCI, which usually includes a stent placement.
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Individually tailored anti-clotting medication dosing significantly cut the rate of adverse events after non-emergent percutaneous coronary intervention (PCI) with stenting, researchers reported at the American Heart Association’s Scientific Sessions 2008. Results of the Tailored Clopidogrel Loading Dose According to Platelet Reactivity Monitoring to Prevent Stent Thrombosis study were presented as a late-breaking clinical trial.
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