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FDA Advisory Committee recommends US FDA approval of BRILINTA (ticagrelor) for Acute Coronary Syndromes
AstraZeneca, 07/29/2010
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AstraZeneca announced that the US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee recommended the FDA approve AstraZeneca's investigational drug ticagrelor for the reduction of thrombotic events in patients with Acute Coronary Syndromes. The review by the Advisory Committee, part of the FDA's evaluation of the New Drug Application submitted for ticagrelor, is based on the results of the large, head–to–head patient outcomes study PLATO. PLATO was designed to establish whether ticagrelor could improve cardiovascular outcomes in ACS patients, compared to clopidogrel. The study design reflected current clinical practice and included all major ACS patient types, whether they underwent invasive procedures or were medically managed.
