Novartis wins FDA approval for Rhapsido in dermographism

The US Food and Drug Administration approved Novartis drug Rhapsido (remibrutinib) on October 7, 2026. The oral Bruton's tyrosine kinase inhibitor is cleared to treat adults with symptomatic dermographism who do not achieve adequate control with H1 antihistamines.

Symptomatic dermographism is a form of chronic inducible urticaria triggered by skin friction, scratching, or rubbing. More than 50% of patients remain symptomatic on H1 antihistamines. Over 90% of adults with chronic hives have either chronic spontaneous urticaria or symptomatic dermographism. Rhapsido is now the only prescription medicine approved for both conditions in the United States.

The approval followed data from the Phase III RemIND clinical trial. By Week 12, 29.3% of patients taking Rhapsido achieved complete hive resolution, compared with 14.0% on placebo. Responses emerged as early as Week 2.

Safety results through Week 24 matched earlier findings in chronic spontaneous urticaria, requiring no routine laboratory monitoring. Adverse events occurring at an incidence of 3% or higher included nasopharyngitis, bleeding, headache, nausea, and abdominal pain. Novartis plans to submit RemIND study results to additional global regulators.