Novartis announced receipt of US FDA approval for Rhapsido (remibrutinib) on October 7, 2026, as the first approved treatment specifically for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines. The decision expands the use of the oral Bruton's tyrosine kinase (BTK) inhibitor, which was first approved for chronic spontaneous urticaria (CSU) in September 2025.
The approval was supported by the Phase III RemIND trial, in which 29.3% of patients receiving Rhapsido achieved complete resolution of hives at Week 12, compared with 14.0% on placebo (p=0.0229). Responses were observed as early as Week 2, while the safety profile was consistent with previous studies in CSU.
Rhapsido works by inhibiting BTK-mediated signaling involved in mast cell activation and histamine release. Beyond SD, Novartis is evaluating remibrutinib in other forms of chronic inducible urticaria, including cold and cholinergic urticaria, and plans further regulatory submissions based on the RemIND dataset.