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UK Regulator OKs Novartis' Treatment for Chronic Spontaneous Urticaria

MT Newswires·08/07/2026 09:58:10
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09:58 AM EDT, 08/07/2026 (MT Newswires) -- The UK's Medicines and Healthcare products Regulatory Agency granted marketing authorization for Novartis' (NOVN.SW) Rhapsido, or remibrutinib, to treat adults with chronic spontaneous urticaria. The drug is authorized for patients with the skin condition whose symptoms are inadequately controlled by H1 antihistamines alone, according to a Thursday release. The decision was supported by the phase 3 Remix-1 and Remix-2 trials, which showed that the drug delivered a statistically significant reduction in itch and hives. Novartis' remibrutinib marks the first oral Bruton's tyrosine kinase inhibitor to receive licensing for chronic spontaneous urticaria.