AstraZeneca’s Brilinta reduced the rate of stroke and death by 17% in patients who had previously experienced a minor acute ischaemic stroke or high-risk transient ischaemic attack (TIA).
Detailed results from the phase 3 THALES trial also showed that Brilinta, given at a dose of 90mg twice-daily alongside aspirin, significantly reduced the rate of ischaemic stroke by 21%, compared to aspirin alone. The drug also reduced the risk for severe bleeding events – in the aspirin group the rate was 0.5%, while in the Brilinta treatment group it was just 0.1%.
“Patients who had an acute ischaemic stroke or transient ischaemic attack may experience a subsequent, potentially avoidable stroke. Results from the phase 3 THALES trial confirm that aspirin plus Brilinta has the potential to be a new effective treatment option for these high-risk patients and we look forward to continuing discussions with regulatory authorities,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AZ.
The positive results make up for previous disappointing data for Brilinta (ticagrelor) in this prevention setting – in 2016, Brilinta administered alone failed to show a significant benefit in reducing the rate of stroke and death in the same indication.
The results of the SOCRATES trial revealed that Brilinta, given at a dose of 90mg twice-daily, was no more effective than a single daily dose of aspirin in preventing stroke, heart attack and/or death when given to patients who had previously suffered a stroke or transient transient ischaemic attack.
The P2Y12 receptor agonist has been an important growth product for AZ and although it had a slow start, has been stacking up research in prevention indications from coronary artery disease to type 2 diabetes. Those indications helped the drug to deliver sales of $1.6bn in 2019, which constitutes a 23% growth over the year driven in particular by a strong performance in emerging markets.
The drug is already approved for the treatment of acute coronary syndrome (ACS) and for the secondary prevention of cardiovascular events among high-risk patients who have experienced a heart attack.
The US Food and Drug Administration (FDA) has already accepted a supplemental new drug application (sNDA) and granted a priority review for Brilinta for the reduction of subsequent stroke in patients who have previously experienced an acute ischaemic stroke or TIA based on the THALES trial.
According to AZ, an action date for this application is due in the fourth quarter, meaning it could launch Brilinta in this indication before the end of the year.