FDA approves Novartis Rhapsido as first treatment for symptomatic dermographism
Novartis has secured FDA approval for Rhapsido as the first treatment specifically approved for symptomatic dermographism in adults inadequately controlled by H1 antihistamines.
Rhapsido (remibrutinib) is an oral selective BTK inhibitor whose expanded indication is supported by the Phase III RemIND trial, in which approximately twice as many treated adults achieved complete hive resolution at Week 12 compared with placebo.
The decision extends Rhapsido beyond chronic spontaneous urticaria into symptomatic dermographism, a form of chronic inducible urticaria.
Field | Content |
Article Type | Approvals |
Drug Name | Rhapsido |
Generic Name | Remibrutinib |
Company | Novartis |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | Expanded indication; first approved treatment for symptomatic dermographism |
Indication | Symptomatic dermographism |
Patient Population | Adults with symptomatic dermographism inadequately controlled by H1 antihistamines |
Therapy Area | Dermatology; immunology; chronic inducible urticaria |
Technology/Modality | Oral selective Bruton's tyrosine kinase inhibitor |
Clinical Study | Phase III RemIND |
Key Clinical Finding | Approximately twice as many Rhapsido-treated adults achieved complete hive resolution at Week 12 compared with placebo |
Previous Indication | Chronic spontaneous urticaria |
New Indication | Symptomatic dermographism |
Geography | United States |
What Happened | The FDA approved Rhapsido for adults with symptomatic dermographism inadequately controlled by H1 antihistamines. |
Why It Matters | The decision establishes the first specifically approved treatment for symptomatic dermographism and introduces an oral targeted therapy for eligible patients. |
Supporting Context | The Phase III RemIND study demonstrated improved complete hive resolution at Week 12 compared with placebo. |
Potential Impact | The expanded indication could provide a new treatment option for adults whose symptoms remain inadequately controlled with antihistamines. |
Key Takeaway | Novartis has secured a first-of-its-kind FDA approval for Rhapsido in symptomatic dermographism. |
What to Watch | US commercial rollout, treatment guideline updates, clinician adoption and longer-term real-world effectiveness and safety. |
Primary Source | Novartis |
Relevant Date | 7 October 2026 |
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