AstraZeneca announced that BRILINTA (ticagrelor) has just been approved by the U.S. Food and Drug Administration to be used as treatment for heart attack patients beyond a year of the incident, reducing rates of cardiovascular death, myocardial infarction (MI) and stroke in those with MI or acute coronary syndrome (ACS).
An oral antiplatelet treatment, BRILINTA works by interfering with platelet activation. Based on data, the drug is superior to clopidogrel at least for the first year following ACS, making it the first oral antiplatelet approved by the FDA to beat clopidogrel in reducing cardiovascular deaths. It can also minimize stent thrombosis in those who received stenting to treat ACS.
BRILINTA is recommended for administration as 90-mg doses, two times a day for the first year following an ACS event. After the first year, the dose can be reduced to 60 mg. For maximum effect, the drug must be used alongside a daily dose of 75 to 100 mg aspirin.
"[The] approval provides an important new treatment option and underscores the role BRILINTA can play in reducing the risk of a subsequent cardiovascular event," said Elisabeth Björk, cardiovascular and metabolic diseases head for AstraZeneca's Global Medicines Development, and vice president for late clinical development.
The expanded indication assigned to BRILINTA was approved under FDA's Priority Review, which grants expedited assessment for medicines determined to carry the potential to offer dramatic improvements in treating, preventing and diagnosing a disease. The drug was earlier approved in 2011 based on the PLATO study, while the expanded indication received approval using data from the PEGASUS-TIMI 54 study.
According to lead investigator Marc Sabatine, M.D., M.P.H., the PEGASUS-TIMI 54 study showed that adding ticagrelor to treatment involving low-dose aspiring for hose who have had prior heart attacks significantly reduced risks of cardiovascular deaths, having a stroke or having another heart attack. He added that it's important for doctors to come up with treatment tailored to individual patient needs but it cannot be ignored that there is benefit to be gained from the addition of ticagrelor.
Between the PLATO and PEGASUS studies, almost 40,000 patients have been involved in studying BRILINTA. The drug has been approved in more than 100 countries now and has been included in 12 major guidelines set forth for treating ACS, including the one released by the American Heart Association/American College of Cardiology.
It is expected that 60-mg BRILINTA tablets will be made available in pharmacies by the end of September.
Photo: Abdul Rahman | Flickr
