The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental new drug application (sNDA) and granted priority review designation for its Brilinta (ticagrelor) tablets to treat patients with a history of heart attacks.
Brilinta is a direct-acting selective and reversibly binding P2Y12 receptor antagonist in a chemical class known as cyclo-pentyl-triazolo-pyrimidines (CPTPs) and it works by inhibiting platelet activation.
AstraZeneca global medicines development and cardiovascular and metabolic diseases head and vice-president Elisabeth Björk said: "Recent research has shown that one in five patients will have a further heart attack, stroke or cardiovascular death in the subsequent three years following a heart attack, even if they are event free after the first 12 months.
"There is a clear need for treatment options beyond the current standard of care of aspirin for the long-term prevention of atherothrombotic cardiovascular events in patients with a history of myocardial infarction."
FDA has accepted sNDA based on the results of the PEGASUS-TIMI 54 study, which is a large-scale outcomes trial with more than 21,000 patients from approximately 1,100 sites in 31 countries in Europe, the Americas, Africa, and Australia-Asia.
The study investigated ticagrelor tablets plus low-dose aspirin, compared to placebo plus low-dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrolment.
PEGASUS-TIMI 54 is part of the firm’s PARTHENON programme and the PlATO study that involved around 18,000 patients was the first study in the programme and is the basis on which ticagrelor was approved in around 100 countries.
PARTHENON studies will also assess ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic attack, and in patients with diabetes and coronary atherosclerosis.