On 6 August 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) reported that it had approved remibrutinib (Rhapsido) 25 mg film-coated tablets for adults with chronic spontaneous urticaria (CSU) whose symptoms are not adequately controlled by antihistamines. The marketing authorisation was granted to Novartis Pharmaceuticals UK Limited on 5 August 2026 through the International Recognition Procedure Route B.

The agency said the approval followed assessment of evidence from two main clinical studies involving 925 adults with CSU for whom H1 antihistamine treatment did not work well enough. According to the MHRA, patients treated with remibrutinib experienced significantly greater reductions in itch and hive symptoms than those given placebo. Remibrutinib works by blocking Bruton's tyrosine kinase (BTK), which the agency said helps reduce inflammation and make symptoms less frequent and less severe.

Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said the approval provides a new treatment option for these adults. The MHRA said it would keep the medicine's safety and effectiveness under close review and monitor safety through the UK Yellow Card scheme.