The Medicines and Healthcare products Regulatory Agency has authorised remibrutinib, marketed as Rhapsido 25 mg film-coated tablets, for adults with chronic spontaneous urticaria whose symptoms remain inadequately controlled by antihistamines. In the agency’s notice, the marketing authorisation is recorded as having been granted to Novartis Pharmaceuticals UK Limited on 5 August 2026. The decision is also notable for the route used. The MHRA says the application was submitted and approved through the International Recognition Procedure Route B, making the regulatory pathway part of the significance of the announcement as well as the medicine itself.
Chronic spontaneous urticaria is described by the MHRA as a long-term condition that causes recurrent hives, itching and swelling. Where standard treatment does not provide enough control, patients can remain symptomatic for extended periods, which is why new licensed options matter in this part of the treatment pathway. According to the agency, remibrutinib works by blocking Bruton’s tyrosine kinase, or BTK. The stated aim is to reduce inflammation and make symptoms less frequent and less severe.
The authorisation follows review of evidence from two main clinical studies involving 925 adults with chronic spontaneous urticaria whose H1 antihistamine treatment had not worked well enough. In the MHRA’s summary, patients treated with remibrutinib showed significantly greater reductions in itch and hive symptoms than those given placebo. That detail matters because the licensed population is specific. The evidence cited by the regulator relates to adults whose CSU remains inadequately controlled by antihistamines, rather than to the whole urticaria pathway.
For patients, the immediate effect is that a further medicine now holds a UK marketing authorisation for this indication. For clinicians, the decision adds another licensed option to consider where antihistamines have not delivered adequate symptom control. The announcement does not remove the need for product-level prescribing review. The Summary of Product Characteristics and the Patient Information Leaflet, both referenced by the MHRA, will carry the detailed information on use and safety that services rely on in practice.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said the approval provides a new treatment option for adults living with chronic spontaneous urticaria whose symptoms are not adequately controlled by antihistamines. He also said the regulator would continue to monitor the medicine’s safety through the Yellow Card scheme and encouraged both patients and healthcare professionals to report suspected side effects. That emphasis reflects the next stage of medicines oversight. Once a product is licensed, routine pharmacovigilance becomes central to identifying suspected adverse reactions in wider clinical use.
In policy terms, the notice is a focused but important licensing decision. It combines a defined indication, evidence from studies involving 925 adults, and a clear post-authorisation reporting route through the Yellow Card scheme. Taken together, the MHRA decision gives the UK a new licensed treatment option for adults with chronic spontaneous urticaria that is not adequately controlled by antihistamines, while keeping the usual regulatory attention on formal product information and ongoing safety monitoring.