Novartis Rhapsido® receives European Commission approval as first oral targeted treatment for chronic spontaneous urticaria

Novartis announced today that the European Commission approved Rhapsido® (remibrutinib) for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1-antihistamine treatment. This is the first oral targeted treatment approved for CSU, providing relief through a pill taken twice daily without lab monitoring. CSU affects nearly 4 million people in Europe, with many continuing to experience debilitating symptoms despite conventional antihistamine therapy. The approval follows a positive opinion from the EMA’s CHMP in February 2026 and inclusion in the 2026 International Guideline for Urticaria. Remibrutinib, a highly selective oral BTK inhibitor, blocks histamine release, easing symptoms of CSU. Early improvements were observed as early as Week 1 in Phase III REMIX-1 and REMIX-2 studies, with favorable safety profiles and no liver concerns. The treatment is also being investigated for other immune-mediated conditions like chronic inducible urticaria and hidradenitis suppurativa. CSU impacts approximately 40 million people worldwide, predominantly affecting women aged 20–40. Symptoms include itchy hives and swelling, often causing sleep deprivation, mental health issues, and reduced productivity. Remibrutinib demonstrated superiority over placebo in itch, hives, and urticaria activity by Week 12 in pivotal trials. Novartis emphasizes the broad potential of this approach beyond CSU, highlighting its role in advancing immune-mediated disease treatment.