FDA Approves Rhapsido, the First Treatment for Skin-Writing Hives
Millions of people with symptomatic dermographism (SD)—sometimes called “skin writing” because even light scratching can cause raised, itchy welts—now have an FDA-approved treatment. On October 7, 2026, the U.S. Food and Drug Administration (FDA) approved Novartis’ oral drug remibrutinib (Rhapsido) for adults whose SD symptoms are inadequately controlled by standard H1 antihistamines.
Rhapsido is a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, taken as a 25 mg tablet twice daily. It blocks the BTK pathway, which contributes to the inflammatory response responsible for hives and itching.
The FDA approval was supported by results from the Phase 3 RemIND trial, which demonstrated statistically significant improvements in symptom control. Remibrutinib is the only prescription treatment approved for both chronic spontaneous urticaria (CSU) and symptomatic dermographism.
SD is the most common form of chronic inducible urticaria. For decades, this group of conditions lacked a dedicated, on-label therapy, leaving dermatologists to rely on off-label approaches. Clinicians and patient advocates have welcomed the approval as a significant step forward in skin health.
The most commonly reported side effects of Rhapsido include:
- Nasopharyngitis
- Bleeding
- Headache
- Nausea
- Abdominal pain
Because of the risk of bleeding, patients are advised to pause treatment 3–7 days before and after surgery.