Novartis Rhapsido®▼(remibrutinib) receives MHRA authorisation as a treatment for eligible adults with chronic spontaneous urticaria (CSU) with inadequate response to H1 antihistamine treatment

This press release is intended for public audiences. This material was created and funded by Novartis Pharmaceuticals UK Ltd.

• The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for remibrutinib for adult CSU patients in the UK who have had an inadequate response to H1 antihistamine treatment¹
• In the UK, while around 400,000 patients live with CSU, the disease remains inadequately controlled for ~50% of patients on the current standard of care (SoC) H1-antihistamines^2,3
• UK marketing authorisation is based on results from the pivotal Phase III REMIX-1 and REMIX-2 trials. These trials demonstrated a statistically significant reduction in itch and hives, measured by the absolute change from baseline in weekly urticaria activity score (UAS7) at week 12 versus placebo¹

London, August 06 2026 – Novartis today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Rhapsido^® (remibrutinib) for adult patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1 antihistamines alone¹. While H1-antihistamines are long considered to be the first-line treatment, more than half of patients today live with uncontrolled disease⁴. Remibrutinib is the first oral Bruton’s tyrosine kinase (BTK) inhibitor licensed for the treatment of CSU¹.

“The nature of CSU means that symptoms such as itching and burning rashes are both severe and unpredictable and can potentially have an impact on a patient’s quality of life”, said Phil Brady, Chief Operating Officer, British Skin Foundation. “It’s encouraging to see that eligible patients may have another oral treatment option to help manage CSU and the impact of its symptoms.”

Marketing authorisation is based on the Phase III REMIX-1 and REMIX-2 trials, which included 925 patients with CSU who remained symptomatic on second-generation H1-antihistamines. Inadequately controlled CSU is defined by the presence of itch and hives for ≥6 consecutive weeks. The primary endpoint was the change from baseline in UAS7 at Week 12. Remibrutinib demonstrated superiority in change from baseline versus placebo (REMIX-1: Remibrutinib -20.0 (n=309) vs -13.8 with placebo (n=153); p<0.001; REMIX-2: Remibrutinib -19.4 (n=297) vs -11.7 with placebo (n=153); p<0.001)¹. All secondary endpoints including Itch (ISS7) and hives (HSS7) were also met.

In the trials, remibrutinib demonstrated an acceptable safety profile which remained consistent up to 52 weeks⁵. The most frequently reported adverse reaction is upper respiratory tract infections (14.7%) such as nasopharyngitis (6.6%) and influenza (2.5%).¹

“Today’s announcement highlights our proud heritage in immunology stemming from over a decade of innovation in this field” said Rob Hastings, Chief Medical Officer, Novartis UK. “This MHRA authorisation is a potential step forward for eligible patients living with CSU in the UK, many of whom are still symptomatic despite treatment with antihistamines.”

About remibrutinib
Remibrutinib is a highly selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of itchy hives (wheals) and swelling^5-7.

About REMIX-1 and REMIX-2
REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) are two identically designed, global, multicenter, randomised, double-blind, parallel-group, placebo-controlled Phase III trials, consisting of 925 patients who remained symptomatic on second-generation H1-antihistamines¹. The primary endpoint was the change from baseline in UAS7 at Week 12. Secondary endpoints included change from baseline in ISS7 and HSS7, and safety analysis. 

About chronic spontaneous urticaria (CSU)
CSU is the medical term for chronic hives that last for 6 weeks or longer, where the underlying cause is internal rather than exposure to any allergen or external trigger^4,7,8. CSU affects approximately 40 million people worldwide^4,9. It is characterised by the sudden appearance of itchy hives (wheals) and/or deep tissue swelling (angioedema), which can occur on the face, throat, hands, and feet^7,10. CSU affects all ages but occurs most frequently between the ages of 20-40 years, with women affected nearly twice as often as men⁷. CSU causes significant emotional distress, with the majority of patients suffering from sleep deprivation, and high rates of mental disorders, such as anxiety or depression, as well as decreased work productivity⁷.

About Novartis 
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.

To reimagine medicine with us, visit our website at https://www.novartis.com/uk-en/ and connect on LinkedIn, Facebook, and Instagram.

UK | August 2026 | FA-11628904