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FDA Approves New Dosage for Ticagrelor (Brilinta)

60-mg tablet to be available next month

The FDA has approved a new dosage of ticagrelor (Brilinta, AstraZeneca) –– 60 mg twice daily –– for patients with a history of heart attack beyond the first year. With this expanded indication, ticagrelor is now approved to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI.

Ticagrelor is an oral antiplatelet treatment that works by inhibiting platelet activation. It was first approved by the FDA in July 2011and is the only oral antiplatelet agent to demonstrate superior reductions in cardiovascular death compared with clopidogrel (Plavix). Ticagrelor also reduces the rate of stent thrombosis in patients who have been stented for the treatment of ACS.

In the management of ACS, the recommended maintenance dosage of Brilinta is 90 mg twice daily during the first year after an ACS event. After 1 year, patients with a history of heart attack can now be treated with 60 mg twice daily. Ticagrelor should be used with a daily maintenance dose of aspirin of 75 to 100 mg.

The expanded indication for ticagrelor was approved under an FDA priority review. The approval was based on data from the PEGASUS TIMI-54 study, an outcomes trial involving more than 21,000 patients. The study investigated ticagrelor tablets plus low-dose aspirin,  compared with 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 to 3 years before study enrollment.

The new 60-mg tablet is expected to be available by the end of September 2015.

Source: AstraZeneca; September 3, 2015.

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