The US Food and Drug Administration (FDA) has approved remibrutinib (Rhapsido) for adults with symptomatic dermographism whose symptoms remain inadequately controlled with H1 antihistamines, according to a Novartis press release.

The approval makes it the first FDA-approved treatment for symptomatic dermographism and expands use of the oral Bruton tyrosine kinase (BTK) inhibitor beyond chronic spontaneous urticaria, for which it was first approved in September 2025.

“With Rhapsido [remibrutinib] now approved for the two most common forms of chronic hives, more people may have the opportunity to find relief from persistent itch, regain confidence in their daily lives, and focus less on their symptoms and more on the moments that matter,” stated Victor Bultó, president, US, Novartis.

Novartis described symptomatic dermographism as the most prevalent form of chronic inducible urticaria, with more than 50% of patients remaining symptomatic despite H1 antihistamine treatment.

The approval was supported by the symptomatic dermographism cohort of the phase 3 RemIND trial, which included patients who remained symptomatic while taking second-generation H1 antihistamines. Remibrutinib was compared with placebo, with complete hive response assessed using the Total Fric Score.

At week 12, 29.3% of patients receiving remibrutinib achieved a complete hive response compared with 14.0% of those receiving placebo. Responses were observed as early as week 2, Novartis reported.

The safety profile in symptomatic dermographism was consistent with the profile reported for chronic spontaneous urticaria, according to Novartis. Through week 24, the most common adverse events, with an incidence of 3% or greater, were nasopharyngitis, bleeding, headache, nausea, and abdominal pain. Routine laboratory monitoring is not required.

Remibrutinib is a highly selective oral BTK inhibitor that blocks the BTK pathway involved in histamine release. In the United States, it is now approved for adults with symptomatic dermographism or chronic spontaneous urticaria whose symptoms are inadequately controlled with H1 antihistamines.

RemIND also evaluated remibrutinib in cold urticaria and cholinergic urticaria. Novartis said it plans to submit the full RemIND dataset to health authorities globally where appropriate. Remibrutinib remains under study in hidradenitis suppurativa, food allergy, and multiple sclerosis.

Source: Novartis