New Brilinta Dose Approved for Heart Attack Patients

The FDA has expanded the use of AstraZeneca’s blood thinner ticagrelor (Brilinta) in a 60 mg dose for patients with a history of heart attack.

Brilinta was originally approved in July 2011 to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) along with 75 to 100 mg of aspirin daily.

The recommended maintenance dose is 90 mg twice a day during the first year after the ACS event. After 1 year, patients with a history of myocardial infarction can now be treated with 60 mg twice a day.

The new 60 mg tablets are anticipated to arrive at pharmacies by the end of September.

Brilinta’s expanded indication was approved under FDA Priority Review and based on results from the PEGASUS-TIMI 54 trial, which compared ticagrelor plus low-dose aspirin with placebo plus aspirin in more than 21,000 patients who had experienced a heart attack 1 to 3 years prior to their enrollment.

The trial data demonstrated that Brilinta significantly reduces the risk of cardiovascular death, myocardial infarction, and stroke compared with placebo.

“While it’s 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,” stated lead trial investigator Marc Sabatine, MD, MPH.