AZ’s Brilique approved in Europe
pharmafile | December 7, 2010 | News story | Sales and Marketing | AZ, AstraZeneca, Brilique, Plavix, acute coronary syndromes, antiplatelet, atherothrombotic events, ticagrelor
European regulator have approved AstraZeneca’s oral antiplatelet Brilique (ticagrelor tablets).
Brilique can now be used for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS).
Once launched it will compete with Sanofi-Aventis’ and Bristol-Myers Squibb’s Plavix (clopidogrel), which is the current gold standard in this therapy area.
Both drugs are designed to keep blood platelets from sticking together in order to prevent potentially dangerous blood clots.
“[We] 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 AstraZeneca chief executive David Brennan.
The marketing authorisation is based in part on the PLATO study, which backed up Brennan’s claims of superiority for the drug.
Treating 54 ACS patients with Brilique instead of Plavix for one year
prevented one atherothrombotic event, while treating 91 patients prevented one cardiovascular death with no increase in major bleeding.
ACS – an umbrella term for conditions from unstable angina to heart attack – affects around 1.4 million people in Europe every year, with 15% of patients dying within a year of their cardiovascular event.
Patients currently receive dual antiplatelet therapy for up to 12 months, followed by longer-term treatment with aspirin on its own.
AstraZeneca will certainly breathe a sigh of relief at the approval of Brilique: in the US, the drug (called Brilinta there) has a less certain future after the FDA delayed its own review by 12 weeks.
A decision from the FDA is expected this month and a positive one will be key if Brilique is to live up to analyst predications $2 billion in peak year sales.
In most European countries Brilique will have to wait a while to be launched. AstraZeneca says “pricing and reimbursement negotiations” mean the drug will not hit these markets until the second half of next year.
The manufacturer is due to begin enrolling patients into PEGASUS-TIMI 54, a new study of Brilique which looks at its efficacy in people who have suffered a heart attack over the past one to three years.
Adam Hill
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