The scope of AstraZeneca’s Brilinta has been significantly expanded in the US after regulators approved its long-term use in patients with a history of heart attack.
The US Food and Drug Administration says the bloodthinner can now be used beyond the first year, which means Brilinta (ticagrelor) is approved to cut the rate of cardiovascular death, heart attack and stroke in patients with acute coronary syndrome (ACS) or a history of heart attack.
One in five patients go on to have a further heart attack, stroke or cardiovascular death in the three years following a heart attack, even if they are event free after the first 12 months, underscoring the need for better long-term treatment options.
Expanded clearance of Brilinta, which came after a speedy priority review, was based on data from the 21,000-patient Phase III PEGASUS TIMI-54 study, which showed that adding the drug to low-aspirin in patients with a prior heart attack significantly reduced the risk of death from cardiovascular causes, another heart attack, or a stroke.
After three years’ treatment with Brilinta, rates of CV death, MI or stroke were 7.85% in the 90mg arm, 7.77% in the 60mg arm, and 9.04% in the placebo arm.