Novartis Rhapsido® receives European Commission approval as first oral targeted treatment for chronic spontaneous urticaria
The European Commission approved Novartis' Rhapsido (remibrutinib) as the first oral targeted treatment for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1-antihistamine treatment. Rhapsido demonstrated significant improvements as early as Week 1 and a favorable safety profile in REMIX 1 & 2 studies.
Novartis' Rhapsido has been approved by the European Commission for treating chronic spontaneous urticaria (CSU) in adults who haven't responded to H1-antihistamine treatment. Rhapsido is an oral treatment taken twice daily without lab monitoring. The approval follows positive opinions from the Committee for Medicinal Products for Human Use and is supported by REMIX-1 and REMIX-2 trials. CSU affects nearly 4 million people in Europe, with over 50% experiencing debilitating symptoms despite conventional antihistamine therapy. Rhapsido blocks the BTK pathway involved in histamine release, relieving CSU symptoms. The treatment is also being investigated for other immune-mediated conditions.
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