First pill of its kind approved in the US to prevent a second stroke
The US Food and Drug Administration has approved Bayer's asundexian for people who have had an ischaemic stroke not caused by the heart, or a high-risk mini-stroke. In a trial of 12,327 patients it cut repeat strokes by 26%. There is a trade-off: somewhat more gut bleeding, especially in people over 75. For now it is approved only in the US; European and Japanese regulators are reviewing it.
Anyone who has had a stroke lives with one fear in particular: that it will happen again. For them, the US Food and Drug Administration has approved a new drug, asundexian (brand name Sunharbo), made by Bayer. It is the first of a new family of blood thinners, factor XIa inhibitors, to reach patients.
It is taken once a day, alongside standard antiplatelet drugs, by adults who have had an ischaemic stroke not caused by the heart, or a high-risk transient ischaemic attack.
12,327 patients and 26% fewer repeat strokes
Approval rests on the OCEANIC-STROKE trial, in which 12,327 patients were randomly given the drug or a placebo and followed for a median of 19 months. Asundexian led to 26% fewer repeat strokes, mainly those caused by clots, according to data reported by Healio.
The trade-off: a little more bleeding
Major bleeding did not rise overall, but it did in people over 75 and in the first 90 days. Gut bleeding also rose, mostly minor. The drug is not recommended for people with moderate or severe liver disease.
When it could reach Europe
For now it is approved only in the US, where shipping starts in late November. The European Medicines Agency and Japan’s regulator are reviewing it. Any change in treatment should be discussed with a neurologist.
