Stroke

Stroke prevention advances with first-in-class drug approved by FDA

Stroke prevention advances with first-in-class drug approved by FDA
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A first-in-class blood thinner has been approved by the US Food and Drug Administration to prevent repeat strokes in people who have recently experienced a serious event or what healthcare professionals call "mini" episodes.

The drug, asundexian (brand name Sunharbo) developed by Bayer has become the first treatment approved in the US designed to prevent blood clots by blocking a specific protein that hasn't been targeted by medications currently on the market.

Sunharbo stops the clotting protein Factor XIa (FXIa), as opposed to existing medications that take aim at a different protein known as Factor Xa.

The approval was granted following positive results from a global Phase 3 study. FXIa is believed to contribute to the development of "pathological thrombus growth and vessel blockage" – aka clotting.

"Asundexian, an oral, once-daily Factor XIa inhibitor, reduces the risk of secondary stroke, in combination with antiplatelet therapy and is the first approved drug in a new class of Factor XIa inhibitors worldwide," Bayer notes in its official news release.

The chances of stroke patients experiencing a secondary episode within five years is estimated to be one in five, which is a significant percentage of people considering how life-threatening such events can be.

"For those who survive a stroke, the risk of another potentially devastating event is highest in the days and weeks after the initial event, and that risk persists over time,” says Ashkan Shoamanesh, M.D., Senior Scientist at Population Health Research Institute, a Joint Institute of Hamilton Health Sciences and McMaster University, Ontario. “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.”

It's estimated nearly 800,000 Americans suffer a stroke each year and it remains one of the biggest killers globally. Secondary strokes can be more dangerous and debilitating than the initial episode, making clot prevention medicine pivotal in reducing this risk.

Source: Bayer

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