MHRA Approves Remibrutinib for Chronic Hives in Adults

When medicines regulators announce a new approval, the wording can feel distant and bureaucratic. This one matters because it is about people living with itching, hives and swelling that standard treatment has not brought under control. On 5 August 2026, the MHRA granted a marketing authorisation to Novartis Pharmaceuticals UK Limited for remibrutinib, sold as Rhapsido 25 mg film-coated tablets, for adults with chronic spontaneous urticaria whose symptoms are not adequately controlled by antihistamines. The agency published the decision on 6 August 2026. (gov.uk) That gives patients and clinicians a new licensed option in the UK. It also gives us a useful chance to slow the story down and separate three things: the illness itself, the medicine, and what an MHRA approval actually means in practice. (gov.uk)

Chronic spontaneous urticaria, usually shortened to CSU, is a long-term condition that causes recurrent hives, itching and swelling. According to the MHRA, the immune system can become overactive in people with CSU, which is why the condition sits in the world of immune-driven inflammation rather than being treated as a simple, short-lived rash. (gov.uk) The key point is that this approval is not for every case of hives. It is specifically for adults whose symptoms are not adequately controlled by antihistamines, so the decision is aimed at people who have already tried a standard treatment route and still need something more. (gov.uk)

According to the MHRA, remibrutinib works by blocking Bruton’s tyrosine kinase, or BTK. If we translate that into plain English, it means the drug is designed to interrupt part of the signalling behind an overactive immune response, with the aim of reducing inflammation so symptoms happen less often and feel less severe. (gov.uk) The evidence reviewed by the regulator included two main clinical studies involving 925 adults with CSU whose H1 antihistamine treatment had not worked well enough. In those studies, patients taking remibrutinib had greater reductions in itch and hive symptoms than patients given placebo. That does not mean it will work identically for every person, but it does explain why the MHRA judged it strong enough to approve as a new treatment option. (gov.uk)

Another detail worth noticing is the route to approval. Remibrutinib was authorised through the International Recognition Procedure, known as the IRP, and specifically through Route B. MHRA guidance says the IRP allows the UK regulator to take account of prior approvals from trusted regulators in places including the EU, the US, Japan and Australia, while still making its own national decision. (gov.uk) **What this means:** this was not an automatic pass. The same MHRA guidance says Route B uses a targeted assessment and has a 110-day timeline, with room for further questions if extra review is needed. In other words, the UK can move faster than a full national route while still checking the evidence for its own market. (gov.uk)

Approval is important, but it is only one part of the story. The government’s own medicines pathway guidance says a UK-wide marketing authorisation is required before a medicine can be sold or supplied in the UK. That is the licensing hurdle remibrutinib has now cleared. (gov.uk) **What this means:** licensed does not automatically mean instantly available to every patient on the NHS. The same guidance explains that health technology evaluation and funding decisions sit alongside regulatory approval, and that NICE evaluates most new licensed medicines for routine NHS funding in England. So when you hear approved, it is safest to read that as legally cleared for use rather than available everywhere tomorrow. (gov.uk)

The MHRA has also been clear that approval does not end scrutiny. In its announcement, the agency said remibrutinib’s safety and effectiveness will stay under close review, and interim executive director Julian Beach encouraged patients and healthcare professionals to report suspected side effects through the Yellow Card scheme. (gov.uk) That final point matters more than it may seem. The Yellow Card site says anyone can report a suspected problem with a medicine, and those reports help the MHRA identify new safety issues as early as possible. This is post-market safety monitoring in action: a medicine can be licensed, prescribed and still watched carefully once it reaches wider real-world use. (yellowcard.mhra.gov.uk)