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News
The FDA has expanded approval of Novartis' remibrutinib (Rhapsido) to treat symptomatic dermographism — a chronic skin condition where friction triggers itchy welts. It's the first FDA-approved therapy specifically for this condition in patients whose symptoms aren't controlled by antihistamines. The drug was already approved for chronic spontaneous urticaria, another form of chronic hives.
The FDA has expanded the approved use of Novartis' remibrutinib (Rhapsido) to include symptomatic dermographism, a form of chronic hives in which scratching, rubbing, or friction on the skin triggers recurring itchy welts. This makes remibrutinib the first FDA-approved treatment specifically for adults with this condition whose symptoms are inadequately controlled by antihistamines.
The approval builds on the drug's existing US clearance for chronic spontaneous urticaria and comes at a notable time for Novartis, whose pipeline has faced increased scrutiny following late-stage setbacks with its cholesterol drug pelacarsen and muscle-wasting therapy del-desiran.
By the Numbers:
Why it matters: For patients with symptomatic dermographism, everyday friction can be debilitating, and until now, no FDA-approved targeted therapy existed. This approval offers a meaningful new treatment option, and with positive late-stage trial results also emerging in relapsing multiple sclerosis, remibrutinib is shaping up to be a significant asset in Novartis' portfolio.
