Remibrutinib – BiotechReality – Information Intelligence System for Biopharma

Novartis announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria (CIndU), demonstrating the potential to become the first targeted therapy for this condition. The trial met its primary endpoints across three prevalent types of chronic inducible urticaria, achieving significantly higher complete response rates versus placebo at Week 12. These clinically meaningful results represent an important advancement in addressing a major unmet need in the treatment of chronic inducible urticaria affecting an estimated 29 million adults worldwide. REMIBRUTINIB DEMONSTRATES CLINICAL EFFICACY IN CHRONIC INDUCIBLE URTICARIA The RemIND trial achieved statistically significant and clinically meaningful results for chronic inducible urticaria treatment. The primary endpoint was met for the three most prevalent types of CIndU: symptomatic dermographism, cold urticaria, and cholinergic urticaria, with complete responses demonstrated across all three CIndU types. These findings represent an important advance in addressing a major unmet need in the treatment of chronic inducible urticaria. The trial's positive results underscore remibrutinib's efficacy in providing complete symptom relief to patients living with these debilitating conditions. Symptomatic dermographism, the most prevalent form of chronic inducible urticaria, was particularly notable in the RemIND trial results. Cold urticaria, another major CIndU subtype, also demonstrated significant improvement with remibrutinib therapy. Additionally, cholinergic urticaria patients showed meaningful clinical benefit from remibrutinib treatment, expanding the drug's potential impact across multiple CIndU populations. 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 chronic inducible urticaria. Today's findings reinforce that remibrutinib could be the first targeted therapy to improve both spontaneous and inducible forms of chronic urticaria, helping address a major gap in care for patients with these chronic conditions. Angelika Jahreis Read More: Novartis Vanrafia® Phase III Data Show Significant Slowing of Kidney Function Decline in IgA Nephropathy Patients REMIBRUTINIB SAFETY PROFILE SUPPORTS CLINICAL USE Beyond efficacy, remibrutinib demonstrated a favorable safety profile in the RemIND trial. The oral BTK inhibitor was well-tolerated across study populations with no liver safety concerns reported. This safety data is critical for patient populations requiring long-term management of chronic inducible urticaria. The absence of hepatic safety signals strengthens remibrutinib's profile as a potential first-line targeted therapy for CIndU patients. The favorable safety and tolerability profile of remibrutinib aligns with data from its approved indication in chronic spontaneous urticaria (CSU), where it is marketed in the US and China under the brand name Rhapsido. The consistent safety profile across indications reinforces remibrutinib's potential as a targeted therapy for chronic urticaria conditions. Patients with chronic inducible urticaria who require long-term treatment can benefit from remibrutinib's proven safety track record in the chronic spontaneous urticaria population. Read More: Novartis Ianalumab Clinches FDA Breakthrough Status, Aiming to Be First Targeted Treatment for Sjögren’s Disease FDA SUBMISSION AND FUTURE REGULATORY PATHWAY Novartis has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking approval of remibrutinib for the treatment of symptomatic dermographism, the most prevalent type of chronic inducible urticaria. This submission marks a significant step toward bringing the first targeted therapy for CIndU to patients in the United States. The FDA sNDA submission represents Novartis's commitment to expediting patient access to this novel chronic inducible urticaria treatment. In the coming months, the complete RemIND trial data set will be submitted to health authorities globally. The trial findings will be presented at upcoming medical congresses, providing the medical and scientific community with detailed insights into remibrutinib's efficacy and safety in chronic inducible urticaria treatment. These presentations will help establish remibrutinib as the first targeted therapy option for CIndU patients worldwide. ABOUT THE REMIND TRIAL The RemIND trial (NCT05976243) is a global, Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety, and tolerability of remibrutinib in adults with chronic inducible urticaria inadequately controlled by H1-antihistamines. The primary endpoint of the RemIND trial was the proportion of complete responders at Week 12, assessed through provocation tests specific to three CIndU subtypes: symptomatic dermographism, cold urticaria, and cholinergic urticaria. The RemIND trial design reflects current best practices in clinical research for chronic inducible urticaria evaluation. By including objective provocation testing specific to each CIndU subtype, the trial provides rigorous evidence of remibrutinib's efficacy in treating chronic inducible urticaria. The positive RemIND trial results validate this methodological approach and support remibrutinib's potential as the first targeted therapy for CIndU. REMIBRUTINIB'S BROADER DEVELOPMENT PIPELINE Beyond its approved indication in chronic spontaneous urticaria and its potential approval in chronic inducible urticaria, remibrutinib is being investigated in other immune-mediated conditions. The compound is currently under clinical development for hidradenitis suppurativa (HS) and food allergy, demonstrating the versatility of the BTK inhibitor approach in immune-mediated disorders. Additionally, remibrutinib is being explored for other indications in Novartis's neuroscience portfolio. This expanded development program reflects Novartis's commitment to leveraging remibrutinib's mechanism of action across multiple therapeutic areas, potentially providing novel treatment options for patients with various immune-mediated and inflammatory conditions. The BTK inhibitor platform continues to show promise beyond chronic urticaria, positioning remibrutinib as a cornerstone therapy in Novartis's immunology portfolio. Information: Novartis Last Modified:

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Novartis Achieves Phase III Remibrutinib Trial Primary Endpoint in Chronic Inducible Urticaria

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