The US Food and Drug Administration has agreed to a speedy review of AstraZeneca's Brilinta (ticagrelor) for the reduction of subsequent stroke in patients who have experienced an acute ischaemic stroke or transient ischaemic attack (TIA).
The marketing application is based on data from the Phase III THALES trial, which showed aspirin plus Brilinta 90mg used twice daily for 30 days resulted in a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone.
“Patients who have had an acute ischaemic stroke or transient ischaemic attack are at high risk of experiencing a subsequent stroke, which may be disabling or fatal. [The] Priority Review reflects Brilinta’s potential as a much-needed treatment option to reduce the rate of subsequent stroke for these patients and we look forward to working with the FDA to make Brilinta available as soon as possible,” commented Mene Pangalos, executive vice president, BioPharmaceuticals R&D, at AZ.
Specific data from the trial have not yet been shared, but are to be published in a peer reviewed journal and presented at an forthcoming medical congress, AZ noted.
Brilinta is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS) and in more than 70 countries for the secondary prevention of cardiovascular events among high-risk patients who have experienced a heart attack.
An approval in combination with aspirin to prevent a second stroke would significantly expand the drug's reach.