The approval of new 60mg dose is indicated to treat patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event.
It expands existing indication to include long-term treatment beyond the first year.
Brilique is an oral antiplatelet treatment for acute coronary syndrome (ACS). It is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines.
Brilique inhibits platelet activation and has been demonstrated to reduce the rate of thrombotic CV events, such as a heart attack or CV death, in patients with ACS.
The Brilique 90mg dose is already approved in the European Union to avoid atherothrombotic events in adults with acute coronary syndrome (ACS).
In the management of ACS, the recommended maintenance dose of Brilique is 90mg twice daily during the initial year following an ACS event.
AstraZeneca executive vice president, global medicines development and 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.
"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."
In September 2015, the US Food and Drug Administration approved AstraZeneca’s Brilinta (ticagrelor) tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year.