FDA approves Brilinta 60 mg tablets

WILMINGTON, Del. — AstraZeneca on Thursday announced that the Food and Drug Administration approved Brilinta (ticagrelor) tablets at a 60 mg dose for patients with a history of heart attack beyond the first year.

Brilinta is intended to reduce the rate of cardiovascular death, heart attack and stroke in patients with acute coronary syndrome.

"We know that patients remain at risk beyond the first year after their heart attack," said Elisabeth Björk, VP and head of Cardiovascular and Metabolic Diseases for AstraZeneca’s global medicines development division. "Today's approval provides an important new treatment option and underscores the role Brilinta can play in reducing the risk of a subsequent cardiovascular event for patients both in the acute setting and in the longer term."

First approved by the FDA in 2011, the oral antiplatelet treatment inhibits platelet activation and reduces the rate of stent thrombosis, according to AstraZeneca.

The recommended maintenance dose of Brilinta is 90 mg twice daily for the first year after an ACS event. It should be used with a daily maintenance dose of aspirin of 75-100 mg.