Novartis(US:NVS) Globenewswire·2026-02-18 06:15Core Insights - Novartis announced positive topline results from the Phase III RemIND trial for oral remibrutinib in chronic inducible urticaria (CIndU), achieving significant complete response rates compared to placebo at Week 12 [1][2][7] - The trial met its primary endpoint across the three most prevalent types of CIndU: symptomatic dermographism, cold urticaria, and cholinergic urticaria, indicating a major advancement in treatment options for this condition [1][2][7] Company Developments - Novartis has submitted a supplemental New Drug Application (sNDA) to the FDA for remibrutinib to treat symptomatic dermographism, the most common type of CIndU [2] - The full data set from the RemIND trial will be submitted to global health authorities, and findings will be presented at upcoming medical congresses [2] Product Information - Remibrutinib is a selective oral BTK inhibitor that blocks the BTK pathway involved in histamine release, which is a key factor in hives and swelling associated with CIndU [3][7] - Currently, remibrutinib is approved in the US and China for adult patients with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines, marketed under the brand name Rhapsido [3] Clinical Trial Details - The RemIND trial is a global Phase III, multicenter, randomized, double-blind, placebo-controlled study assessing the efficacy, safety, and tolerability of remibrutinib in adults with CIndU inadequately controlled by H1-antihistamines [4] - The primary endpoint was the proportion of complete responders at Week 12, evaluated through specific provocation tests for the three CIndU subtypes [4] Market Context - CIndU affects an estimated 0.5% of the population, equating to approximately 29 million people worldwide, and is characterized by hives triggered by identifiable external factors [5][6] - There is currently a significant unmet need for effective treatment options for CIndU, as no approved targeted therapies exist [5][6]