The pharmaceutical company said Tuesday that the Food and Drug Administration approved the new 60-mg strength for Brilinta for use in patients with a history of heart attack beyond the first year.
The dosing of Brilinta in the management of acute coronary syndrome (ACS) is 90 mg twice daily during the first year after an ACS event. After one year, patients with a history of heart attack can now be treated with 60 mg twice daily. Brilinta must be used with a daily maintenance dose of aspirin of 75 mg to 100 mg.
Brilinta is indicated to reduce the rate of cardiovascular death, heart attack and stroke in patients with acute coronary syndrome or a history of heart attacks. According to AstraZeneca, for at least the first 12 months after acute coronary syndrome, Brilinta is superior to clopidogrel.
The company noted that Brilinta is the first and only FDA-approved oral antiplatelet to demonstrate superior reductions in cardiovascular death versus clopidogrel at 12 months.
“Patients continue to be at risk for a second heart attack, even if their first heart attack was more than a year ago, and they continue on the recommended therapies prescribed to them,” stated Tonous Silfani, executive director, cardiovascular thrombosis, and U.S. head of marketing for AstraZeneca. “We wanted to make this new 60-mg dosage strength available as quickly as possible so that health care providers can consider adding Brilinta 60 mg to the treatment regimen for patients with a history of heart attack beyond the first year.”