AstraZeneca has obtained approval from the European Commission for its Brilique (ticagrelor) to treat patients with a history of heart attacks.
Brilique is an oral antiplatelet treatment for acute coronary syndrome (ACS). It works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic CV events, such as a heart attack or CV death, in patients with ACS.
After an initial one-year treatment with Brilique 90mg and aspirin or other dual anti platelet therapy, patients with a history of heart attack can now continue to be treated with lower dose Brilique 60mg twice daily, which should be taken with a daily maintenance dose of aspirin of 75-150mg.
Brilique 90mg is already approved in the EU for the prevention of atherothrombotic events in adults with ACS.
AstraZeneca chief medical officer Sean Bohen said: "A growing body of evidence continues to show that the risk of experiencing a subsequent cardiovascular event continues beyond the first year after a patient has a heart attack.
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"We are committed to finding new treatment solutions for these patients who remain at risk, and today’s approval is an important step forward in meeting this need."
The EU approval of 60mg dose is based on the results from the PEGASUS TIMI-54 study, which involved more than 21,000 patients.
It is applicable to all 28 EU member countries, as well as Iceland, Norway and Liechtenstein.
PEGASUS TIMI-54 investigated ticagrelor tablets plus low-dose aspirin, compared to placebo plus low dose aspirin, for the long-term prevention of cardiovascular (CV) death, heart attack and stroke in patients who had experienced a heart attack one to three years prior to study enrolment.
