Brilinta regulatory update

FDA approved an sNDA from AstraZeneca for a 60 mg dose of Brilinta ticagrelor and to update the label with data from the 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. Brilinta is now approved to reduce the rate of CV death, myocardial infarction (MI) and stroke in patients with acute coronary syndrome (ACS) or a history of MI. The label now notes that Brilinta is superior to clopidogrel for at least the first 12 months following ACS. AZ plans to launch the 60 mg tablet by the end of this month; the pharma markets a 90 mg tablet. The purinergic receptor P2Y G protein-coupled 12 ( P2RY12; P2Y12) antagonist is also approved to reduce the rate of stent thrombosis in patients who have been stented for treatment of ACS. ...