Next-Gen Anticoagulant Lands FDA Nod for Secondary Stroke Prevention
The first-in-class pill cut recurrent ischemic stroke risk by 26% in a Phase 3 trial, with similar major bleeding rates, the company said.
- On Monday, the Food and Drug Administration approved Bayer's Sunharbo 50 mg tablets, the first Factor XIa inhibitor for reducing recurrent stroke risk in adults following mild-to-moderate ischemic stroke or high-risk transient ischemic attack.
- Unlike existing blood thinners blocking Factor Xa, such as Xarelto, Sunharbo inhibits Factor XIa, a protein that amplifies coagulation cascades; this mechanism prevents clot formation while reducing bleeding risks associated with many current treatments.
- In the OCEANIC-STROKE study of 12,327 adults, Sunharbo 50 mg tablets reduced ischemic stroke risk by 26% compared to placebo over a median 14.2 months, with 6.2% of treated patients experiencing secondary strokes versus 8.4% in the placebo group.
- A 30-day supply of Sunharbo will have a list price of $748.50, and stroke neurologists will be a very important part of the drug's early rollout, said Sebastian Guth, chief operating officer of Bayer Pharmaceuticals and president of Bayer U.S.
- Bayer expects Sunharbo to offset declining revenue from older medicines like Xarelto, though future competition includes therapies from Novartis and a joint effort by Bristol Myers Squibb and Johnson & Johnson currently in clinical development.
27 Articles
27 Articles
Bayer wins US FDA approval for Sunharbo to reduce repeat strokes
The US Food and Drug Administration on Monday approved a new type of blood thinner developed by Bayer for the prevention of strokes in patients who have already had one or have had a "mini-stroke."The drug, which has the chemical name asundexian and will be sold under the brand name Sunharbo, is the first approved treatment designed to prevent harmful blood clots by blocking the clotting protein Factor XIa. Current big-selling blood-clot pre…
FDA Approves Sunharbo (Asundexian) to Prevent Repeat Strokes: How It Works and Side Effects
Up to 30 percent of people who’ve had a stroke will experience another in their lifetime. Now, there's a new option to prevent some of these recurrent strokes: a daily pill called Sunharbo (asundexian).e60dc2a1-f33c-4a05-9b50-8e3e8e5976293b4ac644-17f1-43d1-a738-192721e175dae60dc2a1-f33c-4a05-9b50-8e3e8e597629cef459e1-4642-4f6e-9f31-7297f98693cd The oral medication was approved by the U.S. Food and Drug Administration (FDA), in combination with a…
Next-Gen Anticoagulant Lands FDA Nod for Secondary Stroke Prevention
(MedPage Today) -- The FDA approved asundexian (Sunharbo) as the first factor XIa (FXIa) inhibitor for secondary stroke prevention, the agency announced on Monday. Asundexian, an oral, direct, small-molecule inhibitor of FXIa, is indicated for...
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