Novartis Rhapsido Approved in Europe
Analysis based on 7 articles · First reported Apr 27, 2026 · Last updated Apr 27, 2026
The approval of Rhapsido (remibrutinib) by the International — European Commission is a positive development for Novartis, potentially boosting its revenue and market share in the immunology sector. This approval addresses a significant unmet medical need for millions of patients in Europe, indicating a strong market for the new treatment.
The International — European Commission has approved Rhapsido (remibrutinib) by Novartis for the treatment of chronic spontaneous urticaria (CSU) in adult patients who have not responded adequately to H1-antihistamine treatment. This marks Rhapsido as the first oral targeted treatment for CSU in Europe. The approval follows a positive opinion from the European Union — European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in February 2026, based on data from the pivotal REMIX-1 and REMIX-2 Phase III trials. Rhapsido has already received approval from the United States — Food and Drug Administration in September 2025 and is also approved in China. Novartis is also investigating Rhapsido for other immune-mediated conditions, including chronic inducible urticaria, food allergy, and hidradenitis suppurativa.
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