The Food and Drug Administration (FDA) has approved Brilinta (ticagrelor; AstraZeneca) tablets at a new 60mg dose for use in patients with a history of heart attack beyond 12 months.

The expanded indication approval was based on data from the PEGASUS TIMI-54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome – Thrombolysis In Myocardial Infarction Study Group), a large outcomes trial that enrolled over 21,000 patients to compare ticagrelor plus low-dose aspirin vs. placebo plus low-dose aspirin, for the long-term prevention of cardiovascular death, heart attack, and stroke in patients who had experienced a heart attack 1–3 years before study enrollment.

Study results showed that adding ticagrelor to low-dose aspirin in patients with a prior heart attack significantly reduced the risk of death from cardiovascular causes, having another attack, or a stroke.

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Brilinta, a P2Y12 platelet inhibitor, is now indicated to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction. Brilinta also reduces the rate of stent thrombosis in patients who have been stented for treatment of acute coronary syndrome.

Only the 60mg dose is approved for use in patients with a history of myocardial infarction beyond 12 months. The new 60mg strength tablet is expected to launch by the end of September 2015.

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