Novartis has received approval from the European Commission for Rhapsido (remibrutinib), a novel oral therapy for adults suffering from chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines.

The approval positions Rhapsido as the first targeted oral treatment for CSU, offering patients a convenient pill-based therapy taken twice daily without the need for routine laboratory monitoring. The decision follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use earlier this year.

CSU is a chronic and often debilitating condition characterised by persistent itching, hives and swelling that can severely affect quality of life, including sleep, emotional wellbeing and productivity. Experts highlight that the unpredictability of flare-ups makes effective and accessible treatment options critical for patients.

Remibrutinib works by selectively inhibiting Bruton’s Tyrosine Kinase (BTK), a key pathway involved in the release of histamine, which drives the symptoms of CSU. By targeting this pathway, the drug helps reduce itching and swelling, offering improved disease control.

Clinical evidence from the Phase III REMIX-1 and REMIX-2 trials, involving over 900 patients, showed that remibrutinib significantly reduced itch, hives and overall disease activity compared to placebo at 12 weeks. The therapy also demonstrated a favourable safety profile, with commonly reported side effects including mild respiratory symptoms, headache and nausea.

The drug has already been approved in several markets, including the United States and China, and continues to be evaluated for other immune-mediated conditions such as chronic inducible urticaria, hidradenitis suppurativa and food allergies.

With an estimated 40 million people affected globally, CSU remains an area of high unmet medical need. The European approval of Rhapsido represents a significant advancement, providing patients with a faster, more convenient treatment option and reinforcing the shift towards targeted therapies in immunology.