The Food and Drug Administration (FDA) has granted Priority Review of the supplemental New Drug Application for Brilinta (ticagrelor; AstraZeneca), for use in combination with aspirin, to reduce the rate of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA).
The application includes data from the phase 3 THALES trial (n=11,018), which compared treatment with ticagrelor plus aspirin to aspirin alone in preventing new stroke events. Patients were randomized to receive ticagrelor or matching placebo, in addition to aspirin, within 24 hours of onset of acute ischemic stroke or high-risk TIA symptoms and were treated for 30 days.
Results showed that treatment with ticagrelor led to a statistically significant and clinically meaningful reduction in the risk of the primary composite end point of stroke and death, compared with aspirin alone. Additionally, the safety profile of ticagrelor was found to be similar to that seen in previous studies. Full data from the trial will be presented at a future medical meeting and published in a peer-reviewed journal.
“Today’s 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,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D.
A Prescription Drug User Fee Act action date for the application has been set for the fourth quarter of 2020. Recently, the FDA approved Brilinta to reduce the risk of a first myocardial infarction (MI) or stroke in high-risk patients with coronary artery disease.
Brilinta, a P2Y12 platelet inhibitor, is also indicated to reduce the risk of cardiovascular death, MI, and stroke in patients with acute coronary syndrome (ACS) or a history of MI, and to reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS.
For more information visit astrazeneca-us.com.