FDA Adds Symptomatic Dermographism to Remibrutinib's Approved Uses
The FDA expanded the label for the oral BTK inhibitor remibrutinib, marketed as Rhapsido, to treat symptomatic dermographism in adults whose symptoms are not adequately controlled by H1 antihistamines. It is the first prescription drug approved for both chronic spontaneous urticaria and symptomatic dermographism. In a phase III trial, complete response at 12 weeks occurred in 29.3% of remibrutinib-treated patients versus 14.0% with placebo, with some responses appearing by week 2.
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EXPANDED:
The FDA's action broadens use of remibrutinib, an oral BTK inhibitor sold as Rhapsido, for adults with symptomatic derm
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This summary is Al-enhanced to contain extended analysis and broader social context. The original is {NAME); the linked article is the authoritative source. Original headline: “FDA Expands Indication for Urticaria Drug to Treat Symptomatic Dermographism.” Browse more stories.