MHRA Grants Approval for Remibrutinib to Treat Chronic Spontaneous Urticaria in Adults

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for remibrutinib (Rhapsido) in the form of 25 mg film-coated tablets, specifically for treating adults suffering from chronic spontaneous urticaria (CSU) whose symptoms remain inadequately managed by antihistamines. This approval was achieved through the International Recognition Procedure (IRP) Route B.

Understanding Chronic Spontaneous Urticaria

Chronic spontaneous urticaria is a persistent condition characterised by recurrent hives, itching, and swelling. In individuals diagnosed with CSU, the immune system tends to become hyperactive, leading to these distressing symptoms. Remibrutinib functions by inhibiting Bruton’s tyrosine kinase (BTK), thereby helping to diminish inflammation and alleviate the frequency and severity of symptoms.

The decision to approve remibrutinib was based on an evaluation of evidence derived from two pivotal clinical studies involving 925 adults with chronic spontaneous urticaria who had not experienced sufficient relief from H1 antihistamines. Those who received treatment with remibrutinib exhibited markedly greater improvements in both itch and hive symptoms compared to those receiving a placebo.

Expert Commentary on the Approval

Julian Beach, the Interim Executive Director of Healthcare Quality and Access at the MHRA, stated, “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 approved medications, the safety of remibrutinib will continue to be monitored through the UK Yellow Card scheme. The MHRA encourages both patients and healthcare professionals to report any suspected side effects associated with this medication.

Further Information and Resources

This marketing authorisation was officially granted to Novartis Pharmaceuticals UK Limited on 5 August 2026. The product was submitted and subsequently approved via the International Recognition Procedure (IRP) Route B.

For additional details, the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) are available on the MHRA website. Healthcare professionals and patients are also encouraged to report any suspected adverse reactions through the MHRA Yellow Card scheme, accessible at https://yellowcard.mhra.gov.uk.