BASEL, Switzerland — October 7, 2026

Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Rhapsido® (remibrutinib) as the first treatment specifically indicated for adults with symptomatic dermographism (SD) whose symptoms are inadequately controlled by H1 antihistamines. The approval expands the use of the oral, highly selective Bruton’s tyrosine kinase (BTK) inhibitor beyond its established indication in chronic spontaneous urticaria (CSU). SD is a form of chronic inducible urticaria in which skin friction, scratching or rubbing can trigger hives and itching. Novartis said Rhapsido is now the only prescription treatment in the U.S. with approved indications for both CSU and SD, expanding treatment options for patients whose symptoms remain uncontrolled with antihistamines.

Phase 3 RemIND Study Supports SD Approval

The FDA decision is based on results from the SD cohort of the Phase 3 RemIND clinical trial, which evaluated adults who remained symptomatic despite treatment with second-generation H1 antihistamines. Rhapsido demonstrated a higher rate of complete hive response than placebo based on the Total Fric Score. At Week 12, 29.3% of patients receiving Rhapsido achieved complete resolution of hives compared with 14.0% of patients receiving placebo, with the difference reaching statistical significance. Novartis also reported that responses were observed as early as Week 2. The findings supported the company’s regulatory application and the FDA’s approval of remibrutinib for adults with SD inadequately controlled by H1 antihistamines. The RemIND program also evaluated remibrutinib in other forms of chronic inducible urticaria, including cold urticaria and cholinergic urticaria.

Rhapsido Provides Oral BTK Inhibition for Chronic Hives

Rhapsido is an oral, highly selective BTK inhibitor designed to block the BTK pathway involved in the release of histamine, a key driver of hives and swelling. The company said the safety profile observed in SD through 24 weeks was consistent with that previously established in CSU. Reported adverse events occurring in at least 3% of patients included nasopharyngitis, bleeding, headache, nausea and abdominal pain. Novartis also stated that routine laboratory monitoring is not required for Rhapsido. The treatment’s mechanism and clinical development program reflect the company’s broader strategy of investigating BTK inhibition across immune-mediated diseases, with remibrutinib also being studied in conditions including hidradenitis suppurativa, food allergy and multiple sclerosis.

Advertisement

cGxPJobs Banner

Novartis Expands Rhapsido Immunology Program

The SD approval builds on Rhapsido’s established role in chronic spontaneous urticaria, giving Novartis an opportunity to expand treatment access across two major forms of chronic hives. The company plans to submit the full RemIND dataset to health authorities globally where appropriate. Beyond chronic urticaria, Novartis is continuing to evaluate remibrutinib across additional immune-mediated conditions. The company recently reported positive topline results from the Phase 3 REMODEL-1 and REMODEL-2 trials in relapsing multiple sclerosis, further expanding the clinical development program for the BTK inhibitor. The FDA approval in SD therefore represents both a regulatory milestone for patients with symptomatic dermographism and another step in Novartis’ strategy to explore the therapeutic potential of selective BTK inhibition across immunology.

Source::Novartis, press release