UK MHRA Grants Marketing Authorization for Novartis' Rhapsido (remibrutinib) for Chronic Spontaneous Urticaria

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization for Rhapsido (remibrutinib) for adult patients suffering from chronic spontaneous urticaria (CSU) whose symptoms are not adequately controlled by H1 antihistamines alone. This approval positions remibrutinib as the first oral Bruton's tyrosine kinase (BTK) inhibitor to be licensed for the treatment of CSU. The authorization is supported by data from the Phase III REMIX-1 and REMIX-2 trials, which demonstrated the drug's superiority in reducing CSU symptoms compared to placebo.