Outcomes study to boost prospects for AstraZeneca's Brilinta set to begin in fourth quarter

Aiming to provide added support for its blood thinner candidate, Anglo-Swedish drug major AstraZeneca (LSE: ANZ) plans to initiate a large, international, clinical outcomes study for the investigational oral antiplatelet ticagrelor (which uses the trade names Brilinta and Brilique) in collaboration with the US Brigham and Women’s Hospital-based Thrombolysis in Myocardial Infarction (TIMI) Study Group. The PEGASUS-TIMI 54 study is scheduled to begin patient enrolment during the fourth quarter 2010.

Earlier this year, a US Food and Drug Administration advisory panel voted seven to one to recommend approval of the drug (The Pharma Letter July 29) but the FDA has extended the Prescription Drug User Fee Act (PDUFA) date from September 16 to December 16, 2010 (TPL September 15). Also, last month the drug - to be sold in Europe as Brilique - received a positive opinion for the European Medicines Agency’s advisory group (TPL September 26).

Current treatment guidelines for acute coronary syndrome (ACS) patients recommend dual antiplatelet therapy for up to 12 months post-event, followed by longer-term treatment with aspirin alone, the company noted.