AstraZeneca stated that 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 is designed to assess whether Ticagrelor could improve cardiovascular (CV) outcomes in ACS patients, compared to clopidogrel.
AstraZeneca said that it has 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.
Howard Hutchinson, chief medical officer of AstraZeneca, said: “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.”