The European Commission has given the greenlight to AstraZeneca to market ticagrelor (Brilique, to be marketed as Brilinta in U.S.), which is used to prevent atherothrombotic events in acute coronary syndromes (ACS) patients, across its 27 member states within the European Union.
The approval comes on the heels of a positive opinion from the Committee for Medicinal Products for Human Use issued Sept. 23.
In August, the European Society of Cardiology and European Society for Cardio-Thoracic Surgery granted a Class 1B recommendation for ticagrelor, listing the drug as an alternative antiplatelet treatment during myocardial revascularization for ACS patients with STEMI or non-STEMI.
Ticagrelor could be a good alternative for patients who are unable to metabolize clopidogrel due to the presence of loss-of-function CYP2C19 alleles, which can increase their risk of bleeding. Earlier this year, the FDA slapped a black-box warning on clopidogrel for this reason.
Previous clinical trials including PLATO (A Study of PLATelet Inhibition and Patient Outcomes) showed that ticagrelor had better results when compared with clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis). Researchers found that treating 54 ACS patients with ticagrelor compared with clopidogrel for one year prevented one atherothrombotic event and treating 91 patients prevented one cardiovascular death. In addition, the researchers reported no significant difference in major or fatal bleeding events over the course of one-year, 11.6 percent for ticagrelor and 11.2 percent for clopidogrel.
Marketing of the drug is expected to begin in the second half of the year in most markets, according to London-based AstraZeneca.
The FDA’s decision to approve ticagrelor (Brilinta in the U.S.) is still pending and the new drug application is set to be reviewed Dec. 16.