AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved BRILINTA® (ticagrelor) tablets 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, also known as heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI.
BRILINTA is an oral antiplatelet treatment that works by inhibiting platelet activation and 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 oral antiplatelet to demonstrate superior reductions in cardiovascular death. BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS. In the management of ACS, the recommended maintenance dose of BRILINTA is 90mg twice daily during the first year after the ACS event. After one year, patients with a history of heart attack can now be treated with 60mg twice daily.
The expanded indication for BRILINTA has been approved under FDA Priority Review, a designation granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The approval is 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 enrollment.
