Novartis' Rhapsido approved in Europe as first oral targeted treatment for chronic spontaneous urticaria.

Novartis announced that the European Commission has approved Rhapsido (remibrutinib), the first oral targeted treatment for chronic spontaneous urticaria (CSU) in adults who do not respond adequately to H1-antihistamines. Rhapsido offers a twice-daily pill option without the need for lab monitoring, providing fast relief by blocking a key immune pathway involved in CSU symptoms like itching and swelling. This approval marks a significant advance for the nearly 4 million Europeans affected by CSU, many of whom continue to suffer despite conventional treatments. The drug showed positive results in Phase III REMIX-1 and REMIX-2 trials and is recommended in the 2026 International Urticaria Guideline. Novartis is also exploring remibrutinib for other immune-related conditions.