Novartis Marks Breakthrough in CIndU With Remibrutinib

Novartis today announced positive topline results from its pivotal Phase III RemIND study of oral remibrutinib in chronic inducible urticaria (CIndU), marking a major step forward for patients living with the condition.

The trial met its primary endpoint across the three most common forms of CIndU—symptomatic dermographism, cold urticaria, and cholinergic urticaria—showing significantly higher complete response rates compared to placebo at Week 12.

“The positive RemIND trial results across three different types of CIndU underscore the potential of oral remibrutinib to achieve complete symptom relief for people living with CIndU and build on its recent FDA approval in chronic spontaneous urticaria (CSU),” said Angelika Jahreis, global head, immunology development, Novartis.  “Today’s findings reinforce that remibrutinib could be the first targeted therapy to improve spontaneous and inducible forms of chronic urticaria, helping address a major gap in care for people living with these conditions.”

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Novartis has submitted a supplemental New Drug Application to the US Food and Drug Administration seeking approval of remibrutinib for symptomatic dermographism, the most prevalent type of chronic inducible urticaria (CIndU). Full data will be shared with global health authorities and presented at upcoming medical meetings.

Remibrutinib is a highly selective oral BTK inhibitor that blocks the pathway responsible for histamine release, a key trigger of hives and swelling. Already approved in the US and China under the brand name Rhapsido for adults with chronic spontaneous urticaria who do not respond to H1-antihistamines, the therapy is also being studied in other immune-mediated diseases.