Novartis Rhapsido Wins FDA Approval as First Treatment for Symptomatic Dermographism

Key Facts

Novartis announced that Rhapsido (remibrutinib) received FDA approval as the first treatment for symptomatic dermographism (SD). The company said in a statement via GlobeNewswire that the oral drug is indicated for adults whose conditions are inadequately controlled by standard H1 antihistamines.

Phase III trial data demonstrated significant efficacy in hive resolution compared to placebo, with 29.3% of patients achieving a complete response by Week 12. NVSEF closed at $134.22 on October 6, 2026, prior to the announcement of the approval, which addresses a clinical gap where 50% of patients remain symptomatic on standard treatments.