Novartis has secured UK marketing authorisation for Rhapsido (remibrutinib), giving adults with chronic spontaneous urticaria (CSU) access to the first licensed oral Bruton’s tyrosine kinase (BTK) inhibitor for the condition.

 

The Medicines and Healthcare products Regulatory Agency (MHRA) approval comes as more than half of people living with CSU continue to experience uncontrolled disease despite H1 antihistamines, which are the established first-line treatment.

 

“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.”

 

The authorisation is supported by the Phase III REMIX-1 and REMIX-2 trials, which enrolled 925 patients with CSU who remained symptomatic despite treatment with second-generation H1 antihistamines.

 

In both studies, remibrutinib significantly outperformed placebo on the primary endpoint, the change from baseline in UAS7 at Week 12. In REMIX-1, the change was -20.0 for remibrutinib versus -13.8 for placebo, while REMIX-2 recorded changes of -19.4 versus -11.7, respectively.

 

The treatment also met all secondary endpoints, including measures of itching (ISS7) and hives (HSS7).

 

CSU is characterised by recurring itching and hives lasting at least six consecutive weeks, with symptoms that can be persistent, severe and difficult to control.

 

Remibrutinib showed an acceptable safety profile in the trials, with results remaining consistent through 52 weeks. The most frequently reported adverse reaction was upper respiratory tract infection (14.7%), including nasopharyngitis (6.6%) and influenza (2.5%).

 

“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.”