FDA Approves a New Kind of Blood Thinner to Help Prevent Repeat Strokes
Bayer's Sunharbo, the first approved drug in a new class called factor XIa inhibitors, cut the rate of repeat ischemic strokes by about a quarter in a large trial without a significant rise in major bleeding. Here is who it is for, what it costs and what doctors say to watch for.
By MICHAEL GRANTHealth & Medicine · Nov 11, 7:00 PM
WASHINGTON — Americans who survive a stroke live with a hard truth: the risk of another one is high. On Nov. 9, the Food and Drug Administration approved a new kind of medicine designed to lower that risk, the agency announced.
The drug, Bayer's Sunharbo, known generically as asundexian, is a 50-milligram tablet taken once a day, according to the FDA. It is the first approved drug in a class called factor XIa inhibitors.
The FDA approved Sunharbo for adults who have recently had a mild-to-moderate ischemic stroke that did not come from a clot in the heart, or a high-risk transient ischemic attack, often called a mini-stroke, to be taken along with antiplatelet therapy such as aspirin. It is not approved for patients with atrial fibrillation, the irregular heart rhythm that is a major source of stroke-causing clots. BioPharma Dive reported that the drug stumbled in an earlier key study in atrial fibrillation.
The most widely used clot-preventing drugs today, such as Eliquis and Xarelto, block a protein in the clotting system called factor Xa, Reuters reported. Sunharbo targets a different protein, factor XIa. BioPharma Dive explained that factor XIa plays only a minor role in sealing injured blood vessels but…