The European Commission has approved remibrutinib, Novartis’ oral BTK inhibitor, for adults with chronic spontaneous urticaria inadequately controlled by antihistamines, supported by Phase III data showing improved symptom control.
Written By: Dr. Anuja Badgujar, BDS
Reviewed By: Pharmacally Editorial Team
The European Commission has approved Rhapsido® (remibrutinib). Rhapsido® (remibrutinib), developed by Novartis, is an oral Bruton’s tyrosine kinase (BTK) inhibitor that has recently gained regulatory momentum across urticaria indications. In addition to its approval for adults with Chronic spontaneous urticaria (CSU) who remain symptomatic despite H1-antihistamines. The therapy is administered as a twice-daily oral pill and does not require routine laboratory monitoring, offering a new targeted treatment option.
The approval is supported by data from the Phase III REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) trials, which enrolled 925 patients with persistent symptoms despite second-generation H1-antihistamines. In these studies, remibrutinib demonstrated statistically significant improvements compared with placebo in itch severity, hive count, and weekly urticaria activity scores at Week 12.
The treatment showed a safety profile that does not require laboratory monitoring. The most common adverse events (incidence ≥3%) included nasopharyngitis, headache, nausea, abdominal pain, and mild bleeding events.
The decision follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in February 2026 and inclusion in the 2026 international urticaria management guidelines.
Martin Metz Deputy Director, Institute of Allergology, Charité Universitätsmedizin Berlin, Germany emphasized that chronic spontaneous urticaria is a serious condition with unpredictable flares that significantly affect patients’ quality of life, including sleep, emotional wellbeing, and productivity. He noted that remibrutinib offers rapid symptom relief by targeting a key immune pathway, which may help many patients achieve better disease control.
Patrick Horber, M.D., President, International, Novartis described the approval as an important advancement for CSU patients, improving prospects for faster relief and more consistent day-to-day disease management. He also highlighted the broader development of remibrutinib across other immune-mediated conditions, reflecting the wider potential of BTK inhibition.
CSU is a chronic inflammatory skin disorder characterized by recurrent itchy hives and swelling (angioedema) without a clear external trigger. Symptoms persist for more than six weeks and can significantly affect sleep, mental health, and daily functioning. The condition affects an estimated 40 million people worldwide and occurs more frequently in women, typically between the ages of 20 and 40.
Remibrutinib works by selectively inhibiting BTK, a signaling pathway involved in the release of histamine from immune cells. Histamine is a key driver of itching and wheal formation in CSU, and its reduction helps control symptoms more directly than conventional antihistamines.
The therapy has also been approved by the U.S. Food and Drug Administration, reinforcing its role as a targeted, non-injectable treatment option. Expanding its clinical scope, Novartis has reported positive topline results from the Phase III RemIND trial (NCT05976243) in chronic inducible urticaria (CIndU), a related mast cell–driven condition. Together, these developments position remibrutinib as a potential broad-spectrum therapy across urticaria subtypes, with ongoing evaluation in additional immune-mediated diseases.
Reference
About the Writer
Dr. Anuja Badgujar, BDS is a dentist with expertise in US healthcare data and medical data annotation. With four years of experience handling US healthcare datasets, she brings strong domain knowledge and precision to her work. She is also deeply passionate about medical writing, with a focus on translating complex medical information into clear and structured content.