FDA approves first therapy for symptomatic dermographism

The oral BTK inhibitor produced a complete hive response in 29.3% of treated patients at week 12.

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The FDA approved remibrutinib (Rhapsido) for adults with symptomatic dermographism inadequately controlled with H1 antihistamines.
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Remibrutinib is the first FDA-approved treatment for symptomatic dermographism and is also approved for chronic spontaneous urticaria.
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Approval was supported by the symptomatic dermographism cohort of the phase 3 RemIND trial, which compared remibrutinib with placebo.
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At week 12, complete hive response occurred in 29.3% of remibrutinib-treated patients and 14.0% of placebo-treated patients; responses were reported as early as week 2.
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Through week 24, common adverse events included nasopharyngitis, bleeding, headache, nausea, and abdominal pain; routine laboratory monitoring is not required.

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