FDA OKs new indication for AstraZeneca’s Brilinta

The Food and Drug Administration has cleared AstraZeneca’s Brilinta (ticagrelor) to reduce the risk of stroke, a leading cause of disability and death worldwide, in patients with acute ischemic stroke or high-risk transient ischemic attack 

“One in four patients who have had a stroke will experience a second one, with the risk particularly high within the first 30 days. The approval of Brilinta in combination with aspirin is an important advancement to reduce the risk of recurrent stroke and much-awaited good news for physicians and patients.” said Clay Johnston, lead investigator for the THALES Phase III trial and Dean of the Dell Medical School at The University of Texas in Austin.

Mene Pangalos, BioPharmaceuticals R&D executive vice president, said: “In the United States, someone has a stroke every 40 seconds and the impact on a person’s life can be truly devastating. Brilinta is a well-established medicine across patients with coronary artery disease and with today’s approval, we can now expand its potential to patients with an acute ischemic stroke or transient ischemic attack.”

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

Brilinta also is indicated to reduce the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome, or ACS or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel. It also is indicated to reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS, and to reduce the risk of a first MI or stroke in patients with coronary artery disease  at high risk for such events.