MHRA approves remibrutinib for adults with chronic spontaneous urticaria
The UK’s MHRA has authorised remibrutinib for adults with chronic spontaneous urticaria unresponsive to antihistamines, following assessment of two clinical trials involving 925 patients.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for remibrutinib (Rhapsido) 25 mg tablets to treat adults with chronic spontaneous urticaria (CSU) whose symptoms persist despite antihistamine use. The decision was made under the International Recognition Procedure Route B, enabling faster approval based on prior regulatory assessments. CSU is a long-term condition characterised by recurrent hives, itching and swelling due to immune system overactivity.
Remibrutinib works by inhibiting Bruton’s tyrosine kinase (BTK), reducing inflammation and thereby lowering the frequency and severity of symptoms. The approval follows evaluation of two main clinical studies involving 925 adults with CSU inadequately controlled by H1 antihistamines. Patients receiving remibrutinib showed significantly greater reductions in itch and hive symptoms compared with those given a placebo.
The MHRA will continue to monitor the medicine’s safety and efficacy through the UK Yellow Card scheme, encouraging patients and healthcare professionals to report any suspected side effects. This ongoing surveillance aims to ensure the treatment remains safe for long-term use in line with standard regulatory practice for licensed medicines.
The marketing authorisation was granted to Novartis Pharmaceuticals UK Limited on 5 August 2026 via the International Recognition Procedure Route B. Healthcare professionals and patients can access detailed prescribing information in the Summary of Product Characteristics and Patient Information Leaflet on the MHRA website.