The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the marketing application for AstraZeneca’s ticagrelor (Brilique), indicated for the prevention of atherothrombotic events in acute coronary syndrome (ACS) patients.
Upon the recommendations from CHMP, the drug will now be referred to the European Commission that will make the final decision regarding the drug's approval for use throughout the European Union.
The committee’s opinion of the oral antiplatelet treatment was based upon the results of the PLATO (A Study of PLATelet Inhibition and Patient Outcomes) trial, which compared ticagrelor and clopidogrel use in 18,624 ACS patients. Overall, PLATO showed that treating 54 patients with ticagrelor instead of clopidogrel for one year will prevent one cardiovascular death, MI or stroke, and established the superiority of ticagrelor over clopidogrel.
Recently, the FDA decided to extend the review of the new drug application for ticagrelor in the U.S. If approved, the drug will be marketed in the U.S. under the name Brilinta.