The Medicines and Healthcare products Regulatory Agency (MHRA) has approved remibrutinib (Rhapsido) 25 mg film-coated tablets. This new treatment is for adults suffering from chronic spontaneous urticaria (CSU) whose symptoms are not adequately managed by antihistamines.
Chronic spontaneous urticaria is a long-term condition causing recurrent hives, itching, and swelling. Remibrutinib functions by blocking Bruton’s tyrosine kinase (BTK), which helps to lessen inflammation and reduce the frequency and severity of symptoms.
The approval followed an assessment of evidence from two main clinical studies. These studies included 925 adults with CSU for whom H1 antihistamine treatment was not effective enough. Patients receiving remibrutinib experienced significantly greater reductions in itch and hive symptoms when compared to those given a placebo.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, stated that the approval offers a new treatment option for adults living with CSU whose symptoms are not adequately controlled by antihistamines. The MHRA will continue to monitor the drug's safety through the UK Yellow Card scheme.