FDA expands Brilinta approval for long-term use in patients with heart attack history

September 15, 2015

FDA has expanded approval for ticagrelor (Brilinta, AstraZeneca) to include long-term use in patients with a history of heart attack.

FDA has expanded approval for ticagrelor (Brilinta, AstraZeneca) to include long-term use in patients with a history of heart attack.

Brilinta is an oral antiplatelet medication that was originally approved by the FDA in July 2011 and is the first and only oral antiplatelet to demonstrate superior reductions in cardiovascular death compared to clopidogrel. In the management of ACS, the recommended maintenance dose of Brilinta is 90 mg twice daily during the first year after the cardiovascular (CV) event. With the expanded approval, patients with a history of heart attack can now be treated with 60 mg twice daily beyond the first year. 

Related:FDA grants priority review to expand use of Brillinta 

FDA's approval is based on a clinical study which included more than 21,000 patients and demonstrated that both the 60-mg and 90-mg study doses of Brilinta plus low-dose aspirin significantly reduced the rate of atherothrombic events compared to placebo.

According to a company statement from AstraZeneca: “Recent research has shown that 1 in 5 patients will have a further heart attack, stroke or CV death in the subsequent 3 years following a heart attack, even if patients were event free after 12 months. Patients with a history of a heart attack remain at high and persistent risk for recurrent CV events.”

For patients who have been prescribed this drug, the drug manufacturer offers the Brilinta Patient Support Service (BPSS) tool that provides resources and support to help patients and caregivers from hospital discharge throughout the ACS treatment journey.

The new 60-mg tablet will be available in pharmacies by the end of September.

Read next: [BLOG]: The acute coronary syndrome pipeline