The Medicines and Healthcare products Regulatory Agency (MHRA) has approved remibrutinib (Rhapsido) 25mg for the treatment of adults with chronic spontaneous urticaria (CSU).
The film-coated tablets will be used when the 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 selectively blocking Bruton’s tyrosine kinase (BTK) – an enzyme central to mast cell and basophil activation – helping to reduce inflammation and make flare-ups less frequent and less severe.
The medicine was approved through the International Recognition Procedure (IRP) Route B.
It follows evidence from two clinical trials involving 925 adults with CSU.
In both trials, patients taking remibrutinib alongside standard antihistamines reported statistically significant reductions in itch and hive severity compared to those receiving a placebo.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said: “The approval of remibrutinib provides a new treatment option for adults living with chronic spontaneous urticaria whose symptoms are not adequately controlled by antihistamines.”
As with all licensed medicines, MHRA will continue to monitor its safety.
