The Medicines and Healthcare products Regulatory Agency (MHRA) has approved remibrutinib, marketed under the brand name Rhapsido, as a new treatment option for adults living with chronic spontaneous urticaria (CSU) whose symptoms are not adequately controlled by antihistamines.
The approval means eligible patients in the UK may soon have access to an additional medicine designed to help reduce the persistent itching, hives and swelling associated with this long-term skin condition. Remibrutinib is available as a 25 mg film-coated tablet and received approval through the MHRA’s International Recognition Procedure (IRP) Route B.
Chronic spontaneous urticaria is a condition that causes repeated outbreaks of itchy hives and swelling without an obvious external trigger. For many people, symptoms can persist for months or even years, affecting sleep, work, social life and overall quality of life. Although antihistamines are usually the first line of treatment, some patients continue to experience severe symptoms despite taking these medicines.
The MHRA said remibrutinib offers a new treatment approach by targeting the underlying immune response that contributes to chronic spontaneous urticaria. In people with the condition, the immune system can become overactive, leading to inflammation that causes recurring hives and swelling.
Remibrutinib works by blocking Bruton’s tyrosine kinase (BTK), an enzyme involved in immune cell signalling. By inhibiting BTK, the medicine helps reduce inflammation, making episodes of itching, hives and swelling less frequent and less severe.
The regulator’s decision follows a detailed assessment of evidence from two major clinical studies involving 925 adults with chronic spontaneous urticaria whose symptoms were not adequately controlled by H1 antihistamines.
According to the MHRA, patients treated with remibrutinib experienced significantly greater improvements in itching and hive symptoms compared with those who received a placebo. The findings demonstrated that the medicine could provide meaningful symptom relief for adults whose condition had not responded sufficiently to standard antihistamine treatment.
Commenting on the approval, Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said the medicine expands treatment options for patients living with the condition.
“The approval of remibrutinib provides a new treatment option for adults living with chronic spontaneous urticaria whose symptoms are not adequately controlled by antihistamines.”
He added that, as with all licensed medicines, the MHRA will continue monitoring the medicine’s safety through the UK Yellow Card Scheme and encouraged both healthcare professionals and patients to report any suspected side effects.
The marketing authorisation for remibrutinib was granted to Novartis Pharmaceuticals UK Limited on 5 August 2026. The medicine was reviewed and approved through the International Recognition Procedure Route B, a regulatory pathway designed to support timely access to medicines that have already undergone assessment by recognised international regulatory authorities.
Healthcare professionals prescribing remibrutinib will be able to access detailed guidance through the Summary of Product Characteristics, while patients can obtain information about how to take the medicine, possible side effects and safety advice in the Patient Information Leaflet, both of which are available through the MHRA.
The MHRA continues to encourage patients and healthcare professionals to report any suspected adverse reactions through the Yellow Card Scheme, helping regulators monitor the ongoing safety of medicines used across the UK.
The approval of remibrutinib represents another step forward in expanding treatment options for people living with chronic spontaneous urticaria, offering new hope to patients whose symptoms have remained difficult to control despite conventional antihistamine therapy.
Many Nigerians living in the UK manage long-term health conditions while balancing work, family and daily responsibilities. For those living with chronic spontaneous urticaria, access to new treatment options such as remibrutinib could provide improved symptom control and a better quality of life. Anyone experiencing persistent hives, itching or swelling should speak with their GP or specialist to discuss the most appropriate treatment options and never start or stop medication without professional medical advice.
At Chijos News, we are committed to keeping Nigerians in the UK informed about the latest developments in healthcare, medicines, public health and medical innovation. Our mission is to provide trusted, accurate and easy-to-understand health news that helps the Nigerian diaspora make informed decisions about their wellbeing and stay updated on important changes across the UK’s healthcare system.
