ADاشتہار / AdvertisementGoogle Ad
FDA Approves New Blood Thinner to Cut Repeat Strokes by 26%Health
The FDA has approved Sunharbo, the first drug to block clotting protein Factor XIa — a once-daily pill that cut repeat strokes by 26% in a major trial.
Share:
American regulators have approved a new kind of blood thinner that works in a way no approved medicine has before, giving stroke survivors a fresh option to lower the chance of a second stroke.
The US Food and Drug Administration said on Monday that it had cleared Sunharbo, known by its chemical name asundexian, for adults who have recently had a mild or moderate stroke not caused by a clot from the heart, or who have had a high-risk mini-stroke. The once-daily tablet is taken alongside standard antiplatelet treatment.
ADاشتہار / AdvertisementGoogle Ad
What makes the drug different is its target. It blocks a clotting protein called Factor XIa, a step in the clotting chain that today’s medicines do not touch. The big-selling blood thinners Eliquis and Xarelto block a different protein, Factor Xa. Sunharbo is the first Factor XIa inhibitor to win approval.
The decision rests on a large international trial called OCEANIC-STROKE, which enrolled 12,327 adults at 702 centres in 37 countries. Patients began treatment within three days of their stroke or mini-stroke and were followed for a median of 14.2 months.
The results, published in the New England Journal of Medicine, showed that the drug cut the risk of another ischemic stroke — one caused by a blocked artery — by 26 percent compared with a dummy pill. Repeat strokes occurred in 6.2 percent of patients on asundexian, against 8.4 percent of those on placebo.
Bleeding, the main worry with any blood thinner, was only slightly more common with the new drug: major bleeding was recorded in about 1.9 percent of patients taking it, compared with 1.7 percent on placebo. The risk was higher in patients over 75 and during the first three months of treatment, and diarrhoea was the most frequently reported side effect.
The approval does not extend to everyone at risk of stroke. It is not cleared to prevent strokes in people with atrial fibrillation, the irregular heartbeat that can send clots from the heart to the brain, and it is meant only for patients who have already had a stroke or a high-risk mini-stroke.
Bayer, which developed the drug, sees it as a future blockbuster — industry shorthand for a medicine bringing in at least one billion dollars a year in sales — and a way to offset falling revenue from Xarelto, which now faces cheaper generic rivals after losing patent protection. Sebastian Guth, president of Bayer’s US business, called it a practice-changing innovation, noting that repeat-stroke rates have barely moved in 20 years.
China approved the drug late last month, and rivals are not far behind: Novartis is developing abelacimab, while Bristol Myers Squibb and Johnson and Johnson are working on milvexian, although neither has yet reported late-stage stroke-prevention results. No price or launch date for Sunharbo was announced.
Related Coverage
