Novartis Rhapsido® Gains European Commission Approval as First Oral Treatment for Chronic Spontaneous Urticaria

Novartis has received European Commission approval for Rhapsido® (remibrutinib) as the first oral targeted treatment for chronic spontaneous urticaria (CSU) in adult patients who have an inadequate response to H1-antihistamine therapy.

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which was issued on February 27, 2026, recommending marketing authorization for remibrutinib based on data from the pivotal REMIX-1 and REMIX-2 Phase III trials.

Rhapsido, a highly selective oral Bruton’s tyrosine kinase inhibitor (BTKi), demonstrated improvements in itch and hives as early as Week 1 of treatment, with benefits sustained through Week 52 in clinical studies. The therapy also showed improvements in quality of life and sleep, with a favorable safety profile that included no liver safety concerns through Week 52.

The European Commission’s decision marks the first approval of an oral targeted therapy for CSU in Europe, addressing a significant unmet medical need for the nearly 4 million people in Europe living with the condition, over half of whom remain symptomatic despite antihistamine treatment.

Novartis received U.S. Food and Drug Administration (FDA) approval for Rhapsido in September 2025 under the brand name “Rhapsido” for the same patient population, marking it the first FDA-approved oral BTK inhibitor for CSU. The therapy is also approved in China.

Beyond CSU, Novartis is advancing Rhapsido for additional indications, including chronic inducible urticaria, food allergy and hidradenitis suppurativa, based on positive data from the phase III RemIND study and ongoing clinical development.

The approval underscores Novartis’ commitment to reimagine medicine through targeted therapies that address chronic illnesses with significant unmet needs, particularly in immunology and dermatology.