Brilinta ticagrelor: Additional Phase III data

A subgroup analysis of 8,430 ACS patients with ST segment elevation MI (STEMI) in the double-blind, double-dummy, international Phase III PLATO trial showed that 9.4% of patients treated with Brilinta (n=4,201) reached the composite primary endpoint of death from CV death, MI or stroke vs. 11% of patients treated with Plavix clopidogrel (n=4,229) at 12 months (p=0.02). AstraZeneca said the results were driven by a significant reduction in MI for patients receiving Brilinta vs. Plavix (4.7% vs. 6.1%, p=0.01).

No significant difference in the rates of major bleeding was found between the Brilinta and Plavix groups (9% vs. 9.3%, p=0.63). 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 Heart Association meeting in Orlando. Brilinta is under review in the EU to prevent cardiovascular events in ACS patients. Last week, AstraZeneca submitted an NDA to FDA for Brilinta to reduce major adverse cardiac events in ACS patients. ...