After a postmarketing study of AstraZeneca's bleeding reversal agent Andexxa met its primary endpoint earlier than planned, AZ is ending the study at the recommendation of a data monitoring board.
In the study, investigators tested Andexxa versus standard care in more than 450 patients with intracranial bleeding who have received blood thinners called factor Xa inhibitors. Those who received the AstraZeneca drug experienced superior hemostatic efficacy compared with the control arm, AZ said in a Monday release.
Hemostatic efficacy is a measure of the body's ability to stop the flow of life-threatening brain bleeds.
“We are proud to offer the first and only approved treatment to specifically reverse FXa inhibitor activity and help achieve haemostasis, providing an effective and reliable treatment when immediate care is required,” AZ's executive vice president of biopharmaceuticals R&D, Mene Pangalos, Ph.D., said in a statement.
Now, the company will look to convert Andexxa’s speedy approvals in the U.S. and Europe into full nods.
AZ picked up the drug through its $39 billion acquisition of Alexion in late 2020. Alexion got its hands on Andexxa with its $1.4 billion buyout of Portola Pharmaceuticals.
Before winning the accelerated approval in 2018, Portola received a complete response letter on its Andexxa application in 2016 tied to manufacturing questions from the FDA. The company eventually launched the drug in 2019.
Factor Xa inhibitors are blood thinners used to manage clots. They carry a “small but significant” risk of causing serious bleeding, leading to the need for specific reversal agents, AZ pointed out.
Andexxa is a recombinant protein designed to bind to factor Xa inhibitors and reverse their anticoagulant effects. The drug brought in $150 million last year, good for 5% growth from 2021.