FDA approves stroke-prevention pill asundexian

FDA approves new stroke drug

On November 9, the U.S. Food and Drug Administration approved asundexian, a daily pill targeting blood clotting to reduce stroke risk in certain patients.

How the drug works and who it helps

Asundexian, sold as Sunharbo, is approved for people who have recently had an ischemic stroke caused by blood clots or a transient ischemic attack from temporary blockage.

Study shows 26 percent risk reduction

In Bayer's trial, the drug combined with aspirin reduced the risk of an additional stroke by 26% in just over a year compared to placebo plus aspirin.

No increase in bleeding risk

The 26% reduction in stroke risk occurred without any significant increase in bleeding events. Dr. Ashkan Shoamanesh says this solves a longstanding challenge in stroke treatment.

“We used to always have a challenging balancing act. Here we have the major benefits without the bleeding risk, so there is a large amount of excitement.”

Benefits consistent across patient groups

The drug benefited patients regardless of age, geography, medical history or type of ischemic stroke, according to Shoamanesh, who co-led the trial.

Lifelong treatment expected

Asundexian will be available starting in November. Shoamanesh expects patients will need to take the daily pills for the rest of their lives to maintain stroke protection.

“So we expect this to be a lifelong drug based on the data. And we expect this will be the new standard of care.”