MHRA approves remibrutinib for adults with chronic spontaneous urticaria
As with any medicinal product, the MHRA will keep the safety and effectiveness of remibrutinib under close review.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved remibrutinib (Rhapsido) 25 mg film-coated tablets for the treatment of adults with chronic spontaneous urticaria (CSU) whose symptoms are not adequately controlled by antihistamines. Remibrutinib was approved through the International Recognition Procedure (IRP) Route B.
Chronic spontaneous urticaria is a long-term condition that causes recurrent hives, itching and swelling. In people with CSU, the immune system can become overactive. Remibrutinib works by blocking Bruton’s tyrosine kinase (BTK), helping to reduce inflammation and make symptoms less frequent and less severe.
The approval follows assessment of evidence from two main clinical studies involving 925 adults with chronic spontaneous urticaria for whom H1 antihistamine treatment did not work well enough. Patients treated with remibrutinib experienced significantly greater reductions in itch and hive symptoms compared with placebo.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:
The approval of remibrutinib provides a new treatment option for adults living with chronic spontaneous urticaria whose symptoms are not adequately controlled by antihistamines.
As with all licensed medicines, we will continue to monitor its safety through the UK Yellow Card scheme and encourage patients and healthcare professionals to report any suspected side effects.
Notes to editors:
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This marketing authorisation was granted to Novartis Pharmaceuticals UK Limited on 5 August 2026.
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This product was submitted and approved via the International Recognition Procedure (IRP) Route B.
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More information can be found in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) available on the MHRA website.
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Healthcare professionals and patients are encouraged to report suspected adverse reactions via the MHRA Yellow Card scheme at https://yellowcard.mhra.gov.uk.