The regulatory authority has approved Brilinta tablets at a new dose that could be taken along with aspirin beyond a year of heart attack, reported Reuters.
In July 2011, the drug was approved at a higher dose for use in patients during the first year after a heart attack. An oral antiplatelet treatment that works by inhibiting platelet activation, Brilinta was approved based on the data from the PLATO study.
Brilinta prevents blood clots. It reduces the rate of cardiovascular death, myocardial infarction (MI, also known as heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI.
For at least the first 12 months following ACS, Brilinta cuts down the rate of stent thrombosis in patients who have been stented for treatment of ACS.
The recommended maintenance dose of Brilinta is 90mg twice daily during the first year after the ACS event. After one year, patients with a history of heart attack can be treated with 60mg twice daily.
AstraZeneca vice president, head of Cardiovascular and Metabolic Diseases, Global Medicines Development Elisabeth Björk said: "We know that patients remain at risk beyond the first year after their heart attack. Today’s approval is an important milestone that 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."
Brilinta 60mg tablet is expected to be available in pharmacies by the end of this month.