asundexian stroke prevention FDA approval, Digi Mart USA News: The US Food and Drug Administration has approved a first-in-class blood thinner designed to prevent repeat strokes in people who have recently experienced a serious event or so-called “mini” episodes.
The drug, asundexian, brand name Sunharbo, was developed by Bayer. It is the first treatment approved in the US to prevent blood clots by blocking a specific protein, Factor XIa (FXIa), that has not been targeted by medications currently on the market.
Existing medications target a different protein, Factor Xa.
The approval followed positive results from a global Phase 3 study. FXIa is believed to contribute to “pathological thrombus growth and vessel blockage,” meaning clotting.
Bayer describes asundexian as an oral, once-daily Factor XIa inhibitor that reduces the risk of secondary stroke when used in combination with antiplatelet therapy, and as the first approved drug in a new class of Factor XIa inhibitors worldwide.
The chances of a stroke patient experiencing a secondary episode within five years are estimated at one in five. Ashkan Shoamanesh, M.D., Senior Scientist at the Population Health Research Institute, a joint institute of Hamilton Health Sciences and McMaster University, Ontario, said the risk of another event is highest in the days and weeks after the initial stroke and persists over time.
“I believe asundexian introduces an important new addition to post-stroke care that can be used to help patients reduce the risk of a secondary stroke,” he said.
It is estimated that nearly 800,000 Americans suffer a stroke each year, and stroke remains one of the biggest killers globally. Secondary strokes can be more dangerous and debilitating than the initial episode, making clot prevention medicine important in reducing this risk.
