The US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee have recommended the approval of AstraZeneca’s investigational drug ticagrelor for the reduction of thrombotic events in patients with Acute Coronary Syndromes (ACS), by a score of 7 to 1.
The committee’s review – part of the FDA’s evaluation of the New Drug Application (NDA) submitted for ticagrelor – is based on the results of the extensive head-to-head patient outcomes study PLATO (A Study of PLATelet Inhibition and Patient Outcomes). Involving over 18,000 patients from 43 countries, the study was designed to establish whether the drug, to be marketed as Brilinta, could improve cardiovascular outcomes in ACS patients when compared to clopidogrel, otherwise known as Plavix. It 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.
The drug was proven to demonstrate a greater reduction in cardiovascular events after 12 months, without an increase in overall major bleeding; death from vascular causes, myocardial infarction, or stroke occurred in 9.8% of patients on ticagrelor versus 11.7% of those on clopidogrel, a result that delighted Astrazeneca’s chief medical officer Howard Hutchinson.
“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.”
AstraZeneca filed the US regulatory submission for ticagrelor in the second half of 2009, and the drug is also under review in nine other territories around the globe, including the European Union (EU), Canada, and Brazil.