FDA approves Novartis's remibrutinib for symptomatic dermographism

The US Food and Drug Administration (FDA) has approved remibrutinib (brand name Rhapsido) for the treatment of adults with symptomatic dermographism (SD) that is inadequately controlled by H1 antihistamines. This marks the first approved therapy specifically for SD, which is a common form of chronic inducible urticaria.

Developed by Novartis, remibrutinib is an oral Bruton tyrosine kinase (BTK) inhibitor. The approval expands the drug's existing indications, as it was previously approved in 2025 for chronic spontaneous urticaria (CSU). It is currently the only agent indicated for both SD and CSU.

The decision was based on data from the phase 3 RemIND clinical trial. At week 12, 29.3% of patients receiving the 25 mg twice-daily dose achieved a complete response from hives, compared to 14.0% in the placebo group. Clinical responses were observed as early as week two.