US green lights AZ’s Brilinta to reduce risk of stroke

The US Food and Drug Administration (FDA) has approved AstraZeneca’s Brilinta (ticagrelor) to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischaemic attack (TIA).

An ischaemic stroke is caused by a blockage cutting off the blood supply to a region of the brain, while a TIA is a temporary blockage of the blood supply to a region of the brain.

According to AZ, someone has a stroke every 40 seconds in the US and every four minutes someone dies of stroke.

Around one in four strokes are recurrent, with this risk particularly high within the 30 days after the initial event and even higher when looking at time periods closer to the initial event.

The FDA approval was based on results from the phase III THALES trial, which showed that aspirin plus Brilinta 90mg significantly reduced the rate of composite stroke and death compared to aspirin alone in patients with acute ischaemic stroke or TIA.

In particular, Brilinta 90mg used twice daily and taken with daily aspirin for 30 days reduced the rate of stroke and death by 17% compared to aspirin alone in this patient population.

"In the US, someone has a stroke every 40 seconds and the impact on a person’s life can be truly devastating,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D.

“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,” he added.