An application to use AstraZeneca’s Brilinta to treat patients with a history of heart attack has been placed on a fast track regulatory pathway in the US, meaning that approval could be granted within just six months.
The US Food and Drug Administration has assigned a priority review based on Phase III data showing that Brilinta (ticagrelor), along-side low-dose aspirin, can improve long-term prevention of atherothrombotic cardiovascular events in patients with a history of myocardial infarction. The move signals the regulator’s belief that the drug could offer a benefit over existing approaches.
Elisabeth Björk, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, said there is “a clear need for treatment options beyond the current standard of care”, given 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”.
Brilinta is currently available in the US to reduce the rate of thrombotic CV events in patients with Acute Corobary Syndromes, non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]).