US FDA approves Brilinta (ticagrelor) to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease

This license extension was based on positive results from Phase III THEMIS trial, which showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular events at 36 months with aspirin plus ticagrelor 60mg vs. aspirin alone.

SPS commentary:

This is the first regulatory approval for aspirin plus ticagrelor dual antiplatelet therapy in patients who have a high CV risk, but without a history of heart attack or stroke. Potential for a UK license extension is currently unknown.


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