AstraZeneca has announced that the 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 FDA approved oral antiplatelet to demonstrate superior reductions in CV death vs clopidogrel. BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for the treatment of ACS. In the management of ACS, the recommended maintenance dose of BRILINTA is 90mg twice daily during the first year after an ACS event. After one year, patients with a history of heart attack can now be treated with 60mg twice daily. BRILINTA should be used with a daily maintenance dose of aspirin of 75-100mg.
"We know that patients remain at risk beyond the first year after their heart attack," said Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca. "Today's approval provides an important new treatment option and underscores the role BRILINTA can play in reducing the risk of a subsequent cardiovascular event for patients both in the acute setting and in the longer term."
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.
"The PEGASUS-TIMI 54 trial demonstrated that the addition of ticagrelor to low-dose aspirin in patients with a prior heart attack significantly reduced the risk of dying from cardiovascular causes, having another heart attack, or having a stroke," said Marc Sabatine, MD, MPH (Chairman, Thrombolysis in Myocardial Infarction [TIMI] Study Group, Brigham and Women's Hospital, Boston, MA, USA and lead investigator for PEGASUS-TIMI 54). "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."
Between PLATO and now PEGASUS, nearly 40,000 patients have been studied in clinical trials with BRILINTA. BRILINTA has been approved in over 100 countries and is included in 12 major ACS treatment guidelines globally. In the American Heart Association (AHA)/American College of Cardiology (ACC) 2014 NSTE-ACS Guideline, BRILINTA is preferred over clopidogrel for the maintenance treatment in NSTE-ACS patients (Class IIa) and is recommended as a treatment option in the management of NSTE-ACS patients (Class I).
The new BRILINTA 60mg tablet is expected to be available in pharmacies by the end of September 2015.