FDA Grants Priority Review for sNDA for AstraZeneca’s Cardio Drug BrilintaBy
AstraZeneca reports that the US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and granted priority review for Brilinta (ticagrelor) tablets for patients with a history of heart attack. The sNDA is based on the results of a large-scale outcomes trial in more than 21,000 patients that investigated ticagrelor tablets plus low-dose aspirin, compared to placebo plus low-dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrollment. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015.
A priority review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
Brilinta is a direct-acting, selective and reversibly binding P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Brilinta works by inhibiting platelet activation. Brilinta (90 mg) is indicated to reduce the rate of thrombotic CV events in patients with unstable angina, nonâ€“ST-elevation myocardial infarction, or ST-elevation myocardial infarction.