EU Approves Novartis' Rhapsido for Chronic Urticaria Relief

The European Commission has approved Novartis Rhapsido (remibrutinib treatment) for adults suffering from chronic spontaneous urticaria (CSU treatment) who do not respond well to antihistamines. The European Commission approval gives patients in Europe access to a new treatment option for managing this long-term skin condition.

Chronic spontaneous urticaria is an immune-related skin disorder that causes recurring itchy hives, swelling, and irritation on the skin without any clear cause. Symptoms can continue for weeks or months and often affect sleep, daily routines, and emotional wellbeing. Many patients continue to experience discomfort even after using standard antihistamine medicines, especially those with antihistamine-resistant urticaria.

Rhapsido is the first oral targeted therapy approved in Europe for CSU patients who still have symptoms despite antihistamine therapy. Unlike injectable treatments, this medicine is taken as a tablet twice a day, making it a more convenient option for many patients seeking long-term urticaria symptom relief.

The drug works by targeting a protein called Bruton's tyrosine kinase (BTK), making it a Bruton's tyrosine kinase inhibitor. By blocking this pathway, remibrutinib helps reduce the release of histamine — the substance responsible for itching, swelling, and hives. This targeted action may help patients better control flare-ups and improve their quality of life through effective skin allergy treatment.

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The approval is supported by results from two Phase III clinical trials, REMIX-1 and REMIX-2, which included 925 patients worldwide. Study findings showed that patients taking remibrutinib experienced better symptom relief, including reduced itching and fewer hives, compared with those receiving a placebo.

The treatment also showed a manageable safety profile. Common side effects included headache, nausea, sore throat, nasal congestion, and mild stomach discomfort. Another advantage is that the drug does not require regular laboratory monitoring, which may make treatment simpler for both doctors and patients.

CSU affects millions of people globally, especially women, and often appears without warning. Because symptoms can continue for long periods, the condition can significantly impact mental health and everyday life.

Novartis is also studying remibrutinib for other immune-related conditions, including food allergies and certain skin diseases, which may expand its future use in healthcare.