FDA approves new 60mg dose of Brilinta (ticagrelor) in patients with history of heart attack- AstraZeneca

The FDA has approved Brilinta (ticagrelor) tablets, from AstraZeneca, at a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, Brilinta is now approved to reduce the rate of cardiovascular death, myocardial infarction (MI) and stroke in patients with acute coronary syndrome or a history of MI. The new 60 mg tablet is expected to be available in pharmacies by the end of September 2015.

The expanded indication for ticagrelor has been approved under FDA Priority Review, based on the PEGASUS TIMI-54 study, a large-scale outcomes trial involving more than 21,000 patients. PEGASUS TIMI-54 investigated ticagrelor tablets plus low-dose aspirin, compared to placebo plus low-dose aspirin, for the long-term prevention of cardiovascular death, heart attack and stroke in patients who had experienced a heart attack one to three years prior to study enrolment.

Comment: Brilinta was first approved by the FDA in July 2011 on the basis of data from the PLATO study. For at least the first 12 months following ACS, it is superior to clopidogrel and is the first and only FDA approved oral antiplatelet to demonstrate superior reductions in CV death vs clopidogrel. It also reduces the rate of stent thrombosis in patients who have been stented for the treatment of ACS. Brilinta is known as Brilique or Possia in some markets.