FDA Advisory Committee Recommended US FDA Approval of Brilinta (Ticagrelor) for Acute Coronary Syndromes
PharmaLive.com News Archive
AstraZeneca today announced that the US Food and Drug Administration (FDA) 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 (ACS).
The review by the Advisory Committee, part of the FDA’s evaluation of the New Drug Application (NDA) submitted for ticagrelor, is based on the results of the large, head-to-head patient outcomes study PLATO (A Study of PLATelet Inhibition and Patient Outcomes). PLATO was designed to establish whether ticagrelor could improve cardiovascular (CV) outcomes in ACS patients, compared to clopidogrel. The study design reflected current clinical practice and included all major ACS patient types (STEMI and UA/NSTEMI), whether they underwent invasive procedures (PCI, coronary artery bypass graft surgery) or were medically managed.
“We are pleased with the Advisory Committee’s recommendation to support the approval of ticagrelor. We look forward to continued discussions with the FDA as it evaluates the panel’s recommendation and completes its review of the NDA,” said Howard Hutchinson, M.D., Chief Medical Officer, AstraZeneca.
AstraZeneca filed the regulatory submission for ticagrelor, in the second half of 2009. The proposed trade name for ticagrelor in the US is BRILINTA, pending approval from the FDA. Ticagrelor is also currently under regulatory review in nine territories around the world, including the European Union (EU), Canada, and Brazil.
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