Global pharma giant Novartis has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for remibrutinib. The oral therapy is aimed at adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines.

 

“The introduction of remibrutinib represents a major advancement, providing clinicians with an oral Bruton’s tyrosine kinase inhibitor (BTKi) treatment, with improvements in symptoms observed as early as Week 1,” said Martin Metz, Deputy Director, Institute of Allergology, Charité Universitätsmedizin Berlin. 

 

“CSU continues to impose a substantial unmet medical need, as many patients struggle to achieve adequate disease control with currently available therapies.”

 

The recommendation follows robust data from the pivotal REMIX-1 and REMIX-2 Phase III trials, where remibrutinib improved itch and hives within the first week of treatment, with benefits lasting through Week 52. Patients also reported early gains in sleep quality and overall quality of life. Safety data were strong, with no liver-related concerns observed in either study.

 

“People living with CSU often endure years of frustration, and difficulty being taken seriously. For many, the unpredictable itch flare‑ups can make it hard to sleep, focus on daily responsibilities, or even perform their jobs at times,” said Tonya Winders, President and CEO, Global Allergy & Airways Patient Platform (GAAPP). 

 

“The arrival of a new oral treatment option brings us one step closer to ensuring that every person has the opportunity to live fully again.”