Brilinta Approved for Long-Term Use in Patients with History of Heart Attack

Brilinta (ticagrelor) recently received an expanded indication from the US Food and Drug Administration (FDA) for use beyond the first year in patients with a history of heart attack. 

The oral antiplatelet drug from AstraZeneca was originally approved by the FDA in 2011 to reduce the likelihood of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome. During the first year after an acute coronary syndrome event, the recommended maintenance dose of ticagrelor is 90 mg twice daily. 

The expanded indication for a 60-mg maintenance dose allows patients with a history of myocardial infarction to take a 60-mg tablet twice a day, along with a daily maintenance dose of 75–100 mg of aspirin, beyond the first year for continued protection.

“We know that patients remain at risk beyond the first year after their heart attack,” said Elisabeth Björk, head of cardiovascular and metabolic diseases at AstraZeneca. “Today’s approval provides an important new treatment option and 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 expanded indication was approved under FDA priority review and was based on the PEGASUS-TIMI 54 trial. The large-scale study, which included more than 21,000 patients, compared ticagrelor tablets plus low-dose aspirin with placebo plus low-dose aspirin, for long-term prevention of cardiovascular death, heart attack, and stroke in people who had a heart attack 1 to 3 years earlier.

 “The PEGASUS-TIMI 54 trial demonstrated that the addition of ticagrelor to low-dose aspirin in patients with a prior heart attack significantly reduced the risk of dying from cardiovascular causes, having another heart attack, or having a stroke,” said the study’s lead investigator Marc Sabatine, MD, MPH, Brigham and Women’s Hospital, Boston, MA, in a press release.

He continued, “While it is important that physicians tailor their treatment approach for each patient, these data speak to the clinically important benefit that can be gained when adding ticagrelor to the current standard therapy in a patient population at increased risk for recurrent cardiovascular events in the long-term.”

AstraZeneca expected the 60-mg tablets to be available in pharmacies by the end of September.—Jolynn Tumolo