Novartis has secured approval from the European Commission for its novel therapy Rhapsido, marking a significant advancement in the treatment of chronic spontaneous urticaria (CSU). The drug is indicated for adult patients who do not respond adequately to standard H1-antihistamine therapy.
Rhapsido (remibrutinib) is the first approved oral targeted treatment for CSU, offering a new mechanism of action in a convenient pill form taken twice daily. Unlike some existing therapies, it does not require routine laboratory monitoring, which could simplify disease management for both patients and healthcare providers.
CSU, commonly known as chronic hives, is a persistent and often unpredictable condition characterized by intense itching, swelling, and recurrent flare-ups. These symptoms can significantly affect patients’ quality of life, including sleep disruption, emotional distress, and reduced productivity. Experts say there has long been a need for more effective and accessible treatment options, particularly for patients who do not respond to antihistamines.
Clinical experts have welcomed the approval, noting the drug’s potential to address an important unmet need. Professor Martin Metz of Charité Universitätsmedizin Berlin highlighted that CSU is a serious condition with debilitating symptoms and emphasized that Rhapsido works by targeting a key immune pathway involved in the disease. By blocking this pathway, the therapy may help patients achieve faster symptom relief and improved disease control.
The approval follows a positive opinion issued in February 2026 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Additionally, Rhapsido has already been incorporated into the 2026 international guidelines for the management of urticaria, underscoring its clinical relevance and anticipated role in treatment protocols.
Novartis executives described the approval as a meaningful step forward for patients living with CSU. Beyond urticaria, the company is also exploring remibrutinib’s potential in other immune-mediated conditions, including chronic inducible urticaria, food allergies, and hidradenitis suppurativa. This broader development program highlights the promise of targeting the Bruton’s tyrosine kinase (BTK) pathway in a range of inflammatory diseases.
With this approval, Rhapsido introduces a new class of oral therapy that could reshape the treatment landscape for CSU, offering patients a more convenient and potentially more effective option for long-term disease control.