The FDA approved Novartis' twice-daily pill Rhapsido (remibrutinib) as the first treatment for symptomatic dermographism (SD), a form of chronic inducible urticaria in adults whose symptoms aren't adequately controlled by H1 antihistamines.

The clearance arrives just over a year after Rhapsido's initial 2025 approval for chronic spontaneous urticaria (CSU). Combined, CSU and SD account for more than 90 percent of adults living with chronic hives, according to Novartis data cited in the announcement. Rhapsido now stands as the only oral therapy approved for both conditions when antihistamines alone fail.

How does SD differ from CSU?

Chronic spontaneous urticaria triggers hives and itching without an identifiable cause. Symptomatic dermographism sits in the chronic inducible urticaria category, where a defined stimulus — in this case, friction or light pressure — provokes the reaction. Everyday contact points such as a fingernail scratch, a bag strap, or a snug waistband can leave raised, itchy welts in their wake.

What is Rhapsido's mechanism?

Rhapsido is a Bruton's tyrosine kinase (BTK) inhibitor, a newer drug class designed to intervene upstream in the hive cascade. The molecule blocks BTK's role in mast cell degranulation, the release event that floods tissue with histamine and produces welts and itching. It also targets the immune cells responsible for producing the autoantibodies linked to chronic urticaria.

What did the RemIND trial show?

Approval rested on data from Novartis' late-stage RemIND study, which enrolled patients still symptomatic on second-generation antihistamines.

• 29.3% of SD patients on Rhapsido achieved a complete response on the trial's clinical severity measure
• 14% of patients on placebo reached the same benchmark

The company reported a consistent safety profile across the SD and CSU programs for up to 24 weeks.

What does the approval mean for patients?

Victor Bultó, Novartis U.S. president, said the decision gives more patients a path to "find relief from persistent itch" and to spend less time managing symptoms.

What's next in the pipeline?

Novartis is evaluating Rhapsido in additional inducible hives subtypes, including cold urticaria and cholinergic urticaria — the latter triggered by heat or sweating. The drug also received European approval for CSU earlier in 2025, broadening its commercial footprint beyond the U.S.

The new indication positions Rhapsido as the first oral option built to span the two largest chronic hives populations, an advantage Novartis is positioned to leverage as it pushes the molecule into adjacent inducible subtypes.