Brilinta ticagrelor regulatory update

FDA accepted and granted Priority Review to an sNDA for Brilinta ticagrelor to prevent major cardiovascular thrombotic events in patients with a history of myocardial infarction (MI). The PDUFA date is next quarter; a specific date was not disclosed. The application is based on data from the double-blind, international Phase III PEGASUS-TIMI 54 trial in >21,000 patients who had experienced a heart attack 1-3 years prior to the start of the study and who had 1 additional cardiovascular risk factor (see BioCentury, Jan. 19). ...