Health · Pharma & Biotech · 3 hrs ago
FDA approves Bayer’s Sunharbo to reduce the risk of another stroke
The FDA approved Bayer’s Sunharbo to reduce the risk of another stroke in the United States.
The drug is for adults who recently had a mild-to-moderate ischemic stroke not caused by a clot from the heart, or a high-risk transient ischemic attack.
Sunharbo, whose active ingredient is asundexian, is taken with an antiplatelet medicine.
It is the first approved drug in a class that blocks a clotting protein called XIa.
In a large trial, 6.2% of people taking Sunharbo had another stroke, compared with 8.4% taking a placebo, a 26% reduction in risk.
The new approach aims to prevent clots while limiting bleeding risk, a concern with some existing blood thinners.
Bayer gains a new product as sales of its older blood thinner Xarelto face competition from generic drugs.
The U.S. Food and Drug Administration approved Bayer’s asundexian, sold as Sunharbo, to reduce the risk of another stroke.
The approval covers adults who recently had a mild-to-moderate non-cardioembolic ischemic stroke or a transient ischemic attack.
Sunharbo is the first approved drug in a class of medicines that inhibit Factor XIa.
In a Phase 3 trial, 6.2% of patients taking Sunharbo had a recurrent stroke, compared with 8.4% taking a placebo.
STAT reported that the trial results represented a 26% reduction in risk.
- Who
- The FDA approved Bayer’s drug asundexian, sold as Sunharbo.
- What
- It was approved to reduce the risk of another stroke in eligible adults.
- When
- Monday, November 9, 2026.
- Where
- The United States.
- Why
- To reduce recurrent stroke risk in adults who recently had a mild-to-moderate non-cardioembolic ischemic stroke or a transient ischemic attack.
This story does not have two clearly opposing sides.
Bayer ended a Phase 3 trial of asundexian in patients with atrial fibrillation and stroke risk after an unsuccessful result.
Asundexian study data revived investor hopes for a major-selling drug, according to cash.ch.
China approved Sunharbo, according to cash.ch.
The FDA approved Sunharbo to reduce the risk of recurrent stroke.
- Drug
- Asundexian, branded Sunharbo
- Manufacturer
- Bayer
- U.S. approval
- Monday, November 9, 2026
- Trial recurrence rate with Sunharbo
- 6.2%
- Trial recurrence rate with placebo
- 8.4%
- Risk reduction
- 26%