The FDA approved the third thienopyridine agent, prasugrel (Effient, Eli Lilly/Daiichi Sankyo), in July 2009, challenging the U.S. market dominance of clopidogrel (Plavix, Bristol Myers Squibb/Sanofi Aventis). Yet, some cardiologists are being cautious about rapid, widespread adoption, and uptake has been slower than expected. Meanwhile, other options—such as reversible agents—loom on the horizon.
AstraZeneca has submitted its antiplatelet drug, ticagrelor (Brilinta) to the FDA for approval via a new drug application.
In patients who have an acute coronary syndrome with or without ST-segment elevation, treatment with ticagrelor as compared with clopidogrel significantly reduced the rate of death from vascular causes, MI or stroke without an increase in the rate of overall major bleeding, based on the PLATO trial presented Sunday at the European Society of Cardiology (ESC) Congress in Barcelona, Spain. However, researchers found an increase in the rate of non–procedure-related bleeding.
Bristol-Myers Squibb (BMS) has released its 2009 fiscal first quarter results, which show strong financial performance and the execution of two key strategic initiatives.
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Antiplatelet agent ticagrelor (Brilinta, AstraZeneca) reduces death rates without increasing bleeding compared with the current standard treatment of clopidogrel for heart attack patients, based on the PLATO-Invasive trial published online Jan. 13 in the Lancet. An accompanying commentary describes the introduction of ticagrelor as “a landmark event that should redefine the care of patients with acute coronary syndromes (ACS).”
Eli Lilly managed to overcome net losses in the third quarter of 2008 to swing into strong earnings for this year’s third quarter, due to solid sales.
The Medicines Company is discontinuing its phase 3 CHAMPION clinical trial program of antiplatelet drug cangrelor in patients undergoing PCI after failing to prove clinical efficacy as a result of safety findings by the independent Interim Analysis Review Committee (IARC).
The Medicines Company has reported net losses for its fiscal 2009 first quarter results.
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