Brilinta Granted FDA Priority Review

AstraZeneca announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor) for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA).

The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the fourth quarter of 2020.

The sNDA was based on results 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. The results were in line with the known safety profile of Brilinta.

“Patients who have had an acute ischaemic stroke or transient ischemic attack are at high risk of experiencing a subsequent stroke, which may be disabling or fatal. 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,” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said.

The data from the THALES trial will be published in a peer reviewed journal and presented at a forthcoming medical congress.

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. In May 2020, the FDA approved a label update for Brilinta in the US to include the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.

Stroke is the second leading cause of death worldwide, with 6.2 million stroke-related deaths in 2017, of which 2.7 million were due to ischaemic stroke. Patients who experience an acute ischaemic stroke or TIA are at high risk of developing subsequent ischaemic events, with particularly high risk within 30 days after the initial event and the highest risk period being the first 24 hours after the initial event.