New treatment for Urticaria (CSU) moves a step closer

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.  

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. Patients treated with Remibrutinib experienced significantly greater reductions in itch and hive symptoms compared with placebo.  

Allergy UK welcomes the MHRA approval – but notes that Remibrutinib is still under appraisal by the National Institute for Health and Care Excellence (NICE).  

NICE approval is a necessary step towards access to news drugs and treatments being made available on the NHS. Allergy UK clinicians are working with NICE to offer a patient perspective on the benefits of this treatment.  

Find out more about living with CSU