European Commission Approves Brilique™ (Ticagrelor Tablets)

AstraZeneca announced today that the European Commission has granted marketing authorisation to BRILIQUE™ (ticagrelor tablets) 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 on 23rd September and is applicable to the 27 Member States and the 3 European Economic Area countries of the European Union.

“We’re delighted BRILIQUE has received regulatory approval in Europe, and believe it will become an attractive option for physicians seeking a more effective antiplatelet treatment than clopidogrel to reduce their ACS patients’ risk of heart attack and cardiovascular death,” said David Brennan, Chief Executive Officer. “Now that BRILIQUE is approved, we will work with the appropriate health entities, formulary and protocol reviews, and clinicians to bring this important medication to patients as soon as possible.”

Of the markets that will launch BRILIQUE in 2011 in the EU, the majority of launches will occur in the second half of the year due to pricing and reimbursement negotiations.

In August 2010, the European Society of Cardiology (ESC) and the European Society for Cardio-Thoracic Surgery (EACTS) granted a Class 1B recommendation to BRILIQUE in their revised “Guidelines for Myocardial Revascularization”. Under the revised guidelines, BRILIQUE 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).

Ticagrelor is currently under regulatory review in 18 territories around the world.

ACS 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 percent 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, 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 BRILIQUE vs. 11.2% for clopidogrel, p=0.43).

Like all medicines, BRILIQUE can cause side effects, although not every patient will experience them. The most common side effects reported with BRILIQUE were bleeding and shortness of breath. Bleeding occurs commonly with any potent platelet inhibitor. With BRILIQUE, severe bleeding is uncommon, while less severe bleeds such as bruising and nosebleeds are common. Shortness of breath often resolved during BRILIQUE treatment and led uncommonly to patients stopping BRILIQUE in the PLATO study. Other uncommonly reported side effects include headache, dizziness, abdominal pain, diarrhea, rash, itching, and upset stomach.