MHRA Approves Rhapsido for Chronic Spontaneous Urticaria in Adults – Novartis

 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. Remibrutinib was approved through the International Recognition Procedure (IRP) Route B.

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 involving 925 adults with chronic spontaneous urticaria for whom H1 antihistamine treatment did not work well enough. Patients treated with remibrutinib experienced significantly greater reductions in itch and hive symptoms compared with placebo.

Source: Medicines and Healthcare products Regulatory Agency (MHRA), gov.uk/mhra.