Brilinta ticagrelor: Phase II data

Data from the double-blind, Phase II ONSET/OFFSET trial in 123 patients with stable coronary artery disease (CAD) on aspirin therapy showed that Brilinta had greater inhibition of platelet aggregation (IPA) at 0.5, 1, 2, 4, 8 and 24 hours after receiving the initial dose and at 6 weeks vs. Plavix clopidogrel (p<0.0001 for all). At 2 hours post-loading dose, 98% and 90% of patients receiving Brilinta achieved >50% and >70% IPA, respectively, vs. 31% and 16% for Plavix (p<0.0001 for each). Patients received a 180 mg loading dose of Brilinta followed by 90 mg Brilinta twice daily, a 600 mg loading dose of Plavix followed by 75 mg Plavix once daily, or placebo, for 6 weeks. Data were presented at the American Heart Association meeting in Orlando and published in Circulation. 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. ...