Bayer gets first approval for stroke drug asundexian

Bayer's oral Factor XIa inhibitor asundexian has been approved in its first market, China, for secondary stroke prevention, beating its main rival therapy from Bristol Myers Squibb and Johnson & Johnson.

China's National Medical Products Administration (NMPA) has cleared asundexian under the Sunharbo brand for secondary stroke risk reduction after a non-cardioembolic ischaemic stroke or a high-risk transient ischaemic attack (TIA), based on the results of the large-scale OCEANIC-STROKE study.

The green light hands Bayer first-mover advantage in China over BMS/J&J's milvexian, which has not yet been submitted for approval in any market and remains in late-stage clinical development.

In a statement, Bayer said that in China – the world's second-largest pharma market – stroke is the leading cause of death and disability, with cases rising 10% between 2010 and 2021 to reach more than 20 million. Asundexian is also under regulatory review in the US, Europe, and other major markets worldwide.

OCEANIC-STROKE showed that adding asundexian to standard antiplatelet therapy used in these patients achieved a 26% fall in the risk of a secondary stroke compared to placebo, with no increase in the risk of major bleeding complications, which are a perennial concern for anti-clotting therapies.

The drug was also able to reduce the risk of a composite endpoint of cardiovascular death, myocardial infarction (MI), or stroke, as well as death from any cause, MI, or stroke in the study, which was published in the New England Journal of Medicine earlier this year.

Despite current secondary prevention options like aspirin and clopidogrel, one in five patients having an ischaemic stroke will have another within the next five years, with the risk of death rising sharply the second time around.

BMS and J&J are also testing milvexian for a similar secondary stroke prevention indication in the LIBREXIA-STROKE trial, which had been due to generate results later this year but, according to recent predictions, may slip into 2027.

"With the approval of asundexian, we have reached an important milestone and are proud soon to be able to offer physicians in China a new treatment option for stroke survivors after a non-cardioembolic ischemic stroke or high‑risk transient ischemic attack," said Bayer's head of pharma R&D, Christian Rommel.

"We are working with stakeholders and medical communities to support equitable and timely access for eligible patients in China," he added.

Asundexian's future looked in jeopardy a couple of years ago when it failed a phase 3 trial in atrial fibrillation (AF), a much larger indication than stroke prevention. Nevertheless, Bayer stuck with the programme, but trimmed its peak sales forecasts for the drug to €1 billion from around €5 billion. Some analysts think it could eventually reach around €3 billion in annual sales.