Bayer has moved a step closer to bringing its experimental stroke prevention drug asundexian to market.
This was after regulators in the United States and Japan accepted the company’s new drug applications, marking a major milestone in the race to reduce recurrent strokes.
The US FDA granted Priority Review status to the investigational Factor XIa (FXIa) inhibitor, potentially accelerating the approval process for patients recovering from non-cardioembolic ischemic stroke or transient ischemic attack (TIA).
The development comes as stroke remains one of the world’s biggest health threats, affecting nearly 12 million people every year. Even with existing prevention therapies, roughly one in 10 stroke survivors suffers another stroke within a year.
“The acceptances of submissions in key markets represent another milestone in the development of asundexian and in our commitment to secondary stroke care.
"More than 90 million people worldwide are living with the consequences of a stroke, highlighting its significant impact on public health,” said Christian Rommel, Head of Research and Development at Bayer`s Pharmaceuticals Division.
“We are collaborating with health authorities to advance the approval process.”
Bayer said it is also pushing ahead with regulatory filings in other major markets. China’s Center of Drug Evaluation recently accepted the company’s marketing authorization application for asundexian and granted the drug Priority Review designation.
The applications are backed by data from the late-stage Phase III OCEANIC-STROKE trial, which enrolled 12,327 patients worldwide. The study found that asundexian, when used alongside antiplatelet therapy, cut the risk of ischemic stroke by 26% compared to placebo — without increasing major bleeding events.
Researchers say the drug works by targeting Factor XIa, a protein involved in abnormal blood clot formation linked to strokes, while potentially avoiding the heightened bleeding risks associated with traditional blood thinners.
