Almost four years after failing to outperform aspirin in preventing stroke in high-risk patients, AstraZeneca’s Brilinta has hit the mark in a new phase 3 trial.
This time round, AZ evaluated Brilinta (ticagrelor) at a dose of 90-mg twice-daily, taken with aspirin for 30 days, in the phase 3 THALES trial. The combination treatment demonstrated a statistically significant reduction in the risk of the primary endpoint of stroke and death compared to aspirin alone – the full results are due to be presented at an upcoming medical meeting.
AZ has already tried to prove Brilinta’s benefit over aspirin in preventing stroke, but failed to do so in the previous SOCRATES trial. When used on its own by patients who had already suffered a stroke or transient ischaemic attack (TIA), it demonstrated a trend towards fewer subsequent events of stroke, heart attack and/or death, but did not achieve statistical significance.
“Results of the phase 3 THALES trial showed Brilinta, in combination with aspirin, improved outcomes in patients who had experienced a minor acute ischaemic stroke or high-risk transient ischaemic attack. We look forward to sharing the detailed results with health authorities,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AZ.
The P2Y12 receptor agonist has been an important growth product for AZ, and although had a slow start, has been stacking up research in prevention indications from coronary artery disease to type 2 diabetes.
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.
This most recent trial in stroke prevention is important for AZ as it tries to push Brilinta into earlier settings and help boost its sales. In its most recent Q3 results, AZ reported an 11% growth of its cardiovascular, renal and metabolism (CVRM) franchise to $1.1bn, driven primarily by a growth in sales of Brilinta and its SGLT2 inhibitor Farxiga (dapagliflozin).
Although Brilinta has continued to grow, it is unlikely that it will hit AZ’s sales target of $3.5bn by 2023 – it is still, however, a valuable product for the company with sales rising around 21% year-on-year.
The currently only approved drug for the treatment of ischaemic stroke is Genentech’s tissue plasminogen activator (tPA) Activase (alteplase) – although this is a controversial therapy as it has an extremely narrow therapeutic window and has to be given within three hours of stroke onset to be effective.