What did the FDA just approve for chronic hives caused by skin pressure?

Rhapsido is the first FDA-approved treatment specifically for adults with symptomatic dermographism that antihistamines do not control.

On Oct. 7, the FDA expanded approval of Novartis’ remibrutinib, sold as Rhapsido, for symptomatic dermographism—the chronic-hives condition in which rubbing or scratching the skin can trigger itchy welts. It is the first treatment approved specifically for adults whose symptoms are not controlled by antihistamines, giving clinicians a targeted next option rather than simply increasing the same first-line medicine.

In the late-stage trial, 29.3% of people taking remibrutinib had complete hive resolution at 12 weeks versus 14% on placebo, with improvement reported as early as week two. This is a prescription treatment, not a cure or a do-it-yourself option; a clinician should confirm the diagnosis, review risks and interactions, and decide whether inadequate antihistamine control makes it appropriate.