EU CHMP recommends approval of Brilique (ticagrelor) for atherothrombosis- AstraZeneca

AstraZeneca has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Brilique (ticagrelor) 60mg for the treatment of patients with a history of heart attack and at high risk of having a further atherothrombotic event. The opinion states that, treatment may be started as continuation therapy after an initial one-year treatment with dual anti platelet therapy.

The positive CHMP opinion 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 Cardiology Congress (ACC) in March 2015. 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.