As expected, AstraZeneca has got the green light in Europe for its oral bloodthinner Brilique.
The Anglo-Swedish drugmaker said that the European Commission has granted marketing authorisation to Brilique (ticagrelor) for the prevention of atherothrombotic events in adults with acute coronary syndromes (ACS). The green light follows the positive opinion from the Committee for Medicinal Products for Human Use in September.
The approval is principally based on the 18,642-patient PLATO, study which compared the drug with Sanofi-Aventis/Bristol-Myers Squibb's Plavix (clopidogrel). That data 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.
AstraZeneca said that the majority of launches in Europe would occur in the second half of 2011 "due to pricing and reimbursement negotiations". Chief executive David Brennan said the drug, known elsewhere as Brilinta, "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".