FDA grants fast review of AZ's Brilinta to prevent recurring strokes
The FDA has granted a fast review of AstraZeneca’s cardiovascular diseases drug Brilinta (ticagrelor) in the new indication that aims to reduce the chances of patients having recurring strokes.
The faster six-month Priority Review is for an indication covering reduction of subsequent stroke in patients who experienced an acute ischemic stroke, or transient ischemic attack (TIA).
This sets up a potential decision date in the final quarter of the year, AZ said in a statement.
The filing was based on results from the phase 3 THALES trial, which showed aspirin plus Brilinta 90 mg 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.
There were no surprises in terms of safety, with results in line with those seen in previous trials.
The data from the THALES trial will be published in a peer reviewed journal and presented at a forthcoming medical congress.
An anti-platelet drug, Brilinta was first approved in 2011 to reduce cardiovascular death and heart attack in patients with acute coronary syndromes.
Since then it has been approved by the FDA in a new crushed form for those unable to take tablets, and for long-term use in patients with a history of heart attack in 2015.
At the beginning of last month AZ added another indication to reduce risk of a first heart attack or stroke in high-risk patients with coronary artery disease.
A blockbuster with sales of more than $400 million in Q2, Brilinta is in a highly competitive market where many doctors may choose the cheaper option of prescribing generic clopidogrel, originally marketed by Sanofi under the brand name Plavix.
It has a direct competitor from Eli Lilly, Effient (prasugrel), which also works by inhibiting production of platelets by targeting a receptor known as P2Y12-ADP.
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.
