Novartis’s Rhapsido has received approval from the European Commission as the first oral targeted therapy for patients with chronic spontaneous urticaria (CSU), marking a significant advancement in treatment options for the condition.
Rhapsido is approved for use in adults with CSU who remain symptomatic despite standard antihistamine treatment, addressing a population with persistent unmet medical need. The therapy offers a novel oral alternative compared to existing injectable biologic treatments.
The approval is supported by data from the Phase III REMIX clinical trial programme, which demonstrated rapid and sustained improvements in symptom control compared with placebo. Patients treated with Rhapsido showed meaningful reductions in itch severity and hive activity, key measures of disease burden in CSU.
Chronic spontaneous urticaria is estimated to affect up to 1% of the global population, with a significant proportion of patients experiencing inadequate control with current therapies. The introduction of an oral targeted option is expected to improve accessibility and convenience for long-term disease management.
From a commercial perspective, the approval positions Rhapsido as a first-in-class oral therapy in CSU, expanding Novartis’ immunology portfolio. The shift from injectable to oral treatment could drive broader patient adoption and market penetration, potentially contributing to future revenue growth in the dermatology and immunology segment.
