EU approves Brilique (ticagrelor) for patients at risk of atherothrombotic events- AstraZeneca

The European Commission has granted marketing authorisation for Brilique (ticagrelor), from AstraZeneca, at a new 60mg dose for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event. Treatment may be started as continuation therapy after an initial one-year treatment with Brilique 90mg and aspirin or other dual anti platelet therapy.

The EU approval was based on the results from the PEGASUS TIMI-54 study, a large-scale outcomes trial involving more than 21,000 patients, presented at American College of Cardiology Congress (ACC) in March 2015 and simultaneously published in the New England Journal of Medicine. PEGASUS TIMI-54 investigated ticagrelor tablets plus low-dose aspirin, compared to placebo plus low dose aspirin, for the long-term prevention of cardiovascular (CV) death, heart attack and stroke in patients who had experienced a heart attack one to three years prior to study enrollment. The study showed that Brilique significantly reduced the primary endpoint of CV death, MI or stroke compared to placebo. The rates at 3 years were 7.77% in the ticagrelor 60mg arm and 9.04% in the placebo arm.

Comment: This follows the approval on 3 September 2015 of BRILINTA (ticagrelor) 60mg by the US Food and Drug Administration, to be used in patients with a history of heart attack beyond the first year.