Brilinta regulatory update

FDA approved an NDA from AstraZeneca for Brilinta ticagrelor to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS). The label includes a boxed warning about the increased risk of significant and sometimes fatal bleeding and contraindications for patients with a history of intracranial hemorrhage, active pathological bleeding or severe hepatic impairment. The warning also states that aspirin doses above 100 mg per day reduce the effectiveness of Brilinta and should be avoided. FDA approved the drug with a REMS under which the company must educate physicians about the risk of higher aspirin doses. ...