Brilinta ticagrelor: Additional Phase III data

A subgroup analysis of 1,261 ACS patients undergoing coronary artery bypass graft (CABG) surgery in the double-blind, double-dummy, international Phase III PLATO trial showed that 10.5% of patients treated with Brilinta (n=632) reached the composite primary endpoint of death from CV death, MI or stroke vs. 12.6% of patients treated with Plavix clopidogrel (n=629) at 12 months (p=0.29). On secondary endpoints, compared with Plavix, Brilinta significantly reduced CV death (4% vs. 7.5%, p<0.01) and the rate of death from any cause (4.6% vs. 9.2%, p<0.01). No significant difference in the rates of major bleeding was found between the Brilinta and Plavix groups. Patients received twice-daily 90 mg oral Brilinta or once-daily 75 mg oral Plavix, an ADP receptor antagonist from Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY, Paris, France). Data were presented at the American College of Cardiology meeting in Atlanta. Brilinta is under review in the EU to prevent cardiovascular events in ACS patients. Last November, AstraZeneca submitted an NDA to FDA for Brilinta to reduce major adverse cardiac events in ACS patients. ...