AstraZeneca has received US Food and Drug Administration (FDA) approval for the new 60mg dose of its Brilinta (ticagrelor) tablets for patients with a history of heart attacks or acute coronary syndrome (ACS).
Approved under FDA Priority Review, the expanded indication of Brilinta is now used to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI.
Brilinta is an oral antiplatelet treatment that works by inhibiting platelet activation.
In July 2011, the drug was approved at a higher dose for use in patients during the first year after a heart attack and was based on data from the PLATO study.
The company noted that for at least the first 12 months following ACS, Brilinta is more effective than clopidogrel and is the first and only oral antiplatelet to show superior reductions in cardiovascular death.
The drug also reduces 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 an ACS event and after one year, patients with a history of heart attack can be treated with 60mg twice-daily.
AstraZeneca vice-president 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."
The 60mg dose of Brilinta was approved based on data from the Pegasus TIMI-54 study, a large-scale outcomes trial involving more than 21,000 patients.
The trial evaluated ticagrelor tablets plus low-dose aspirin, compared to placebo plus low dose aspirin, for the long-term prevention of cardiovascular death, heart attacks and strokes in patients who had experienced a heart attack one to three years prior to enrolment in the trial.
So far, Brilinta has been approved in more than 100 countries and is included in 12 major ACS treatment guidelines globally.
The company said that the new Brilinta 60mg tablet will be available in pharmacies by the end of this month.