Novartis Rhapsido® receives European Commission approval as first oral targeted treatment for chronic spontaneous urticaria
Basel, April 27, 2026 – Novartis announced today that the European Commission (EC) approved Rhapsido ® (remibrutinib) for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1-antihistamine treatment. Rhapsido is the first oral targeted treatment approved for CSU, offering a unique approach to CSU treatment in a pill taken twice daily without any lab monitoring required 1.
“CSU is a serious disease that causes debilitating symptoms, like itch and swelling, with unpredictable flares that greatly impact patients' emotional wellbeing, sleep, and productivity,” says Prof. Dr med. Martin Metz, Deputy Director, Institute of Allergology, Charité Universitätsmedizin Berlin, Germany. “The approval of Rhapsido marks a major step forward, offering fast relief by blocking a key immune pathway, which may help a broad range of patients experience significant control of their disease.”
Rhapsido received a positive opinion in February 2026 from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is included in the 2026 International Guideline for the Definition, Classification, Diagnosis and Management of Urticaria 2.
“Today’s approval represents an important advance for CSU patients, offering new hope for faster relief and better day to day disease control. Rhapsido is being developed for multiple immune-mediated conditions in addition to CSU— such as chronic inducible urticaria, food allergy, hidradenitis suppurativa—highlighting the broad potential of a targeted oral BTK pathway approach,” said Patrick Horber, M.D., President, International, Novartis.
About Remibrutinib
Remibrutinib is a highly selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of itchy hives (wheals) and swelling 6-8. By reducing histamine release, Remibrutinib helps relieve the symptoms of chronic spontaneous urticaria (CSU) 9,10. Remibrutinib is approved in the US,China and several other countries for the treatment of adult patients with CSU who have an inadequate response to H1-antihistamines. Remibrutinib has shown positive topline results in chronic inducible urticaria (CIndU) across the three most prevalent subtypes in the pivotal Phase III RemIND trial. It is also being investigated in other immune-mediated conditions, such as hidradenitis suppurativa (HS) and food allergy, in addition to other indications in the company’s Neuroscience portfolio 11-15.
About REMIX-1 and REMIX-2
REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) are two identically designed, global, multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III trials, consisting of 925 patients who remained symptomatic on second-generation H1-antihistamines. Remibrutinib demonstrated superiority in change from baseline versus placebo in itch, hives, and weekly urticaria activity at Week 12. Remibrutinib has a demonstrated safety profile that requires no lab monitoring. The most common adverse events (incidence ≥3%) were nasal congestion, sore throat, and runny nose (nasopharyngitis), bleeding, headache, nausea, and abdominal pain 15,16.
About chronic spontaneous urticaria (CSU)
CSU is a chronic skin condition affecting approximately 40 million people worldwide 5,18, impacting nearly twice as many women than men 8 and occurring most frequently between the ages of 20-40 years. It is characterized by the sudden appearance of itchy hives (wheals) and/or deep tissue swelling (angioedema), which can appear on the face, throat, hands, and feet 8,19 and occur without exposure to any allergen or external trigger 5 , 8 ,1 7. Symptoms last for 6 weeks or longer and cause significant physical and emotional distress. The majority of CSU patients suffer from sleep deprivation, and high rates of mental disorders, such as anxiety or depression, as well as decreased work productivity 8.
About Novartis Immunology
At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology.
Disclaimer
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About Novartis
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