Novartis Reports Positive Phase III RemIND Results For Remibrutinib In Chronic Inducible Urticaria, Files sNDA With FDA

Novartis has reported positive topline results from its pivotal Phase III RemIND trial evaluating oral remibrutinib in patients with chronic inducible urticaria (CIndU). The study met its primary endpoint across the three most common forms of the condition, symptomatic dermographism, cold urticaria, and cholinergic urticaria, demonstrating significantly higher complete response rates compared to placebo at Week 12. The results highlight remibrutinib’s potential to become the first targeted therapy specifically approved for CIndU, addressing a substantial unmet medical need.

Following these findings, Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking approval of remibrutinib for symptomatic dermographism, the most prevalent subtype of CIndU. The company plans to submit the full clinical dataset to regulatory authorities worldwide in the coming months, and detailed results from the RemIND trial will be presented at upcoming medical congresses.

“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.”

Remibrutinib is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor designed to block the BTK signalling pathway responsible for histamine release, a central driver of hives and swelling in urticaria. By inhibiting histamine release, the therapy aims to reduce symptom severity and improve disease control. In the United States and China, remibrutinib is already approved under the brand name Rhapsido for adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines. Beyond urticaria, the drug is being studied in additional immune-mediated diseases, including hidradenitis suppurativa and food allergies, as well as other neurological indications within Novartis’ pipeline.