The United States Food and Drug Administration has approved asundexian, sold under the brand name Sunharbo, as the first drug in a new class of oral anticoagulants called factor XIa inhibitors, Bayer announced on Tuesday 10 November, according to Pharmacy Times and TCTMD. The drug is approved to reduce the risk of another stroke in adults who have recently had a mild-to-moderate noncardioembolic ischaemic stroke — a clot that did not come from the heart — or a high-risk transient ischaemic attack, often called a mini-stroke. The FDA's own release announcing the approval is dated 9 November, with Bayer's announcement following on 10 November.
Sunharbo is taken as a 50 mg tablet once a day, in combination with antiplatelet therapy, according to Pharmacy Times. It covers adults whose recent stroke scored 15 or less on the National Institutes of Health Stroke Scale, or who had a high-risk transient ischaemic attack, based on the patients in the trial that supported the approval. It is not approved to prevent strokes in patients with atrial fibrillation, according to TCTMD.
The approval rests on the phase 3 OCEANIC-STROKE trial, a double-blind, randomised, placebo-controlled study conducted at 702 centres in 37 countries and enrolling 12,327 patients, according to Pharmacy Times. Full results from the trial have been published in the New England Journal of Medicine. Added to antiplatelet therapy, asundexian reduced the risk of ischaemic stroke by 26 percent compared with antiplatelet therapy alone over a median treatment period of 14.2 months, according to TCTMD and Zacks, with similar rates of major bleeding in both groups.
Experts welcomed the approval as an important advance. Dr Ashkan Shoamanesh of McMaster University in Canada, a co-principal investigator of the trial, said it offers "a new opportunity to prevent recurrent strokes, preserve brain health, and protect our patients from the disability and loss of independence that can follow another stroke", according to TCTMD. Experts also cautioned that cost could slow initial uptake: Bayer has set a list price of $748.50 for a 30-day supply, according to TCTMD.
Bayer expects to start shipping Sunharbo in the United States in mid-to-late November, with hospitals and pharmacies able to order it soon after, according to TCTMD. The drug was already approved in China last month, and marketing applications in Europe, Japan and other markets are still under review, according to Pharmacy Times. As the first factor XIa inhibitor approved anywhere in the world, according to Bayer and the FDA, Sunharbo opens a new class of stroke-prevention treatment — but how widely it is used will depend on pricing, access and how doctors weigh it against existing antiplatelet options.