European Commission has granted marketing authorisation to Brilique ( Ticagrelor ) for the prevention of atherothrombotic events in adult patients with acute coronary syndromes ( ACS ). This decision follows the positive opinion from the Committee for Medicinal Products for Human Use ( CHMP ).

In August 2010, the European Society of Cardiology ( ESC ) and the European Society for Cardio-Thoracic Surgery ( EACTS ) granted a Class 1B recommendation to Ticagrelor in their revised Guidelines for Myocardial Revascularization. Under the revised guidelines, Ticagrelor is listed as an antiplatelet treatment option during myocardial revascularization for ACS patients presenting with ST-elevation myocardial infarction ( STEMI ) or non-ST-elevation myocardial infarction ( NSTEMI ).

Acute coronary syndrome affects an estimated 1.4 million people in Europe every year. Despite the availability of current treatment options for ACS, data suggests that up to 15% of patients die within one year of their cardiovascular event.

The marketing authorisation for Brilique is based on a review of the Ticagrelor clinical programme, including results from PLATO ( A Study of PLATelet Inhibition and Patient Outcomes ), which established the superiority of Ticagrelor over Clopidogrel ( Plavix ), and showed that treating 54 ACS patients with Ticagrelor instead of Clopidogrel for one year prevented one atherothrombotic event and treating 91 patients prevented one cardiovascular death, with no increase in overall major/fatal bleeding over the course of one year of treatment ( 11.6% for Ticagrelor vs 11.2% for Clopidogrel, p=0.43 ).

The most common side effects reported with Ticagrelor were bleeding and shortness of breath. Bleeding occurs commonly with any potent platelet inhibitor. With Ticagrelor, severe bleeding is uncommon, while less severe bleeds such as bruising and nosebleeds are common. Shortness of breath often resolved during Ticagrelor treatment and led uncommonly to patients stopping Ticagrelor in the PLATO study. Other uncommonly reported side effects include headache, dizziness, abdominal pain, diarrhea, rash, itching, and upset stomach.

Ticagrelor is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines ( CPTPs ). Ticagrelor is the first reversibly-binding oral ADP receptor antagonist.

Brilique, a prescription oral antiplatelet treatment, co-administered with Acetylsalicylic Acid ( ASA, Aspirin ), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes ( unstable angina, NSTEMI, or STEMI ), including patients managed medically and those who are managed with percutaneous coronary intervention ( PCI ) or coronary artery bypass grafting ( CABG ).

Source: EMA, 2010

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