Novartis remibrutinib delivered comprehensive disease control in Phase III RMS trials, with proven, robust safety profile

• Remibrutinib achieved significant and clinically meaningful reduction in relapses vs. teriflunomide, to approximately 1 relapse every 13 years, without the need for chronic B-cell depletion¹˒²
• MRI disease activity significantly reduced with remibrutinib vs. teriflunomide in two trials, including reductions in T2 lesion activity by 65% and 70%, and Gd+ T1 lesions by 66% across both trials¹
• Over 92% of remibrutinib patients remained free from disease progression as assessed by 6-month CDP, showing clinically meaningful delay of nearly 30% vs. teriflunomide with nominal significance¹
• No liver safety signal observed, including no Hy’s Law cases, consistent with proven, robust safety profile of remibrutinib in chronic spontaneous urticaria and symptomatic dermographism¹˒³^-⁵

Basel, October 23, 2026 – Novartis today presented positive results from the pivotal Phase III REMODEL-1 and REMODEL-2 trials in relapsing multiple sclerosis (RMS) showing that remibrutinib, a highly selective and efficacious oral Bruton’s tyrosine kinase (BTK) inhibitor, demonstrated superior relapse control and a clinically meaningful delay in disease progression versus teriflunomide with no liver safety signal.¹˒⁶˒⁷ The study results were presented during a late-breaking session at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting, and were published simultaneously in The Lancet.¹˒⁸

“The REMODEL trial results showed that oral remibrutinib delivered a significant reduction in relapse activity while also showing a clinically meaningful effect on confirmed disability progression in people living with relapsing MS,” said Prof. Dr. Heinz Wiendl, Professor of Neurology and Chair of the Department of Neurology and Neurophysiology at the Medical Center, University of Freiburg. “As treatment goals in MS continue to evolve beyond relapse control alone, these efficacy findings, together with the favorable safety profile, suggest remibrutinib has the potential to deliver a meaningful, differentiated treatment option for people living with RMS.”

Remibrutinib reduced the annualized relapse rate (ARR) versus teriflunomide (REMODEL-1: 0.073 vs. 0.112; REMODEL-2: 0.080 vs. 0.116), the primary endpoint of both trials, with statistically significant and clinically meaningful 35.2% and 31.2% relative reduction, translating to approximately one relapse every 13 years.¹ Remibrutinib achieved a clinically meaningful delay in disability progression, reducing the risk of 6-month confirmed disability progression (6mCDP) by 29.2%, with nominal significance, and a consistent positive trend of 20.5% reduction in 3-month confirmed disability progression (3mCDP).¹ More than 92% of patients receiving remibrutinib remained free from disease progression over 24 months as assessed by 6mCDP.¹

In addition to the efficacy findings, remibrutinib demonstrated no liver safety signal, including no Hy’s Law cases, which have been reported in other late-stage BTK inhibitor programs.¹˒⁹ Across both trials, patients treated with remibrutinib experienced fewer liver enzyme elevations at every threshold, including ALT >3×ULN in 2.0% of patients versus 7.4% with teriflunomide, with the remibrutinib arm rate in range with that seen in placebo groups in prior RMS trials.¹˒⁷˒⁹^-¹³ In pooled analyses, treatment discontinuations due to adverse events (AEs) were nearly 50% fewer with remibrutinib than teriflunomide (3.1% vs. 5.8%).¹

Remibrutinib is a highly selective, covalent, oral BTK inhibitor that blocks the BTK pathway, reducing activation of B cells and innate immune cells to modulate immune regulatory networks and related neuroinflammation.⁶˒⁷ Designed to modulate BTK signaling without chronic B-cell depletion, remibrutinib represents a differentiated approach to immune regulation.²˒¹⁴ In preclinical studies, remibrutinib demonstrated the highest BTK selectivity among tested BTK inhibitors.¹⁵

“Novartis has a two-decade legacy developing therapies in multiple sclerosis and continues to advance innovation for people living with the disease,” said Shreeram Aradhye, President, Development, and Chief Medical Officer, Novartis. “The Phase III REMODEL results reinforce our confidence in remibrutinib and its potential to expand treatment choice for people living with RMS. By combining high efficacy with a favorable safety profile through a selective mechanism, remibrutinib has the potential to support long-term disease management without chronic B-cell depletion and to redefine what may be possible across the MS journey.”

Additional efficacy findings
Remibrutinib demonstrated superiority versus teriflunomide on all key secondary endpoints within each trial, including significantly reducing disease activity in the brain, as evidenced by MRI scans.¹ Compared with teriflunomide, remibrutinib significantly reduced annualized T2 lesion activity, a marker of chronic disease burden (REMODEL-1: 0.94 vs. 2.71; REMODEL-2: 0.82 vs. 2.77), and significantly reduced the rate of Gd+ T1 lesions per scan, a marker of active inflammation (REMODEL-1: 0.08 vs. 0.24; REMODEL-2: 0.07 vs. 0.21).¹ Serum neurofilament light chain (NfL) outcomes were significantly improved by 9.0% in REMODEL-1 (11.57 vs. 12.73) and 7.0% in REMODEL-2 (12.05 vs. 13.00) versus teriflunomide.¹

In the preplanned pooled REMODEL-1/2 analysis, patients receiving remibrutinib had approximately three times higher odds of achieving overall disease control versus patients receiving teriflunomide.¹ A nominally significant difference in NEDA-3 was observed, with 55.0% of patients receiving remibrutinib achieving no evidence of disease activity across three domains: relapses, disability progression and MRI activity, versus 32.1% of patients receiving teriflunomide.¹

Additional safety findings
The safety profile of remibrutinib was consistent with the broader development program.¹˒³^-⁵˒¹⁶ Numerically fewer patients receiving remibrutinib experienced AEs (79.5% vs. 81.5%) and serious AEs (6.0% vs. 7.0%) than those receiving teriflunomide.¹ Two deaths occurred in the remibrutinib group and were both assessed by investigators as unrelated to study treatment: one accidental carbon monoxide poisoning, for which suicide was ruled out, and one completed suicide.¹ 

Novartis plans to seek regulatory approval for remibrutinib in RMS globally. 

About multiple sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage in the brain, optic nerves and spinal cord.¹⁷ MS, which affects nearly 3 million people worldwide, can be characterized into three main types: non-active secondary progressive (SPMS), primary progressive (PPMS), and relapsing MS (RMS).¹⁸˒¹⁹ RMS is the most common form and includes clinically isolated syndrome (CIS), relapsing-remitting (RRMS), and active SPMS.¹⁹ The various forms of MS are distinguished by how the disease presents and progresses, including whether patients experience relapses, worsening disability over time, or a combination of both.²⁰

About remibrutinib
Discovered at Novartis, remibrutinib is being investigated in the Phase III REMODEL trials in relapsing multiple sclerosis (RMS) and Phase III REMASTER trial in secondary progressive MS (SPMS). ²¹^-²³ Remibrutinib is also being studied in other immune-mediated conditions, such as hidradenitis suppurativa and food allergy.²⁴˒²⁵ Remibrutinib 25 mg was approved for the treatment of adults with chronic spontaneous urticaria (CSU) under the brand name Rhapsido® by the FDA in September 2025 and by the European Medicines Agency in April 2026. ²⁶˒²⁷ In October 2026, Rhapsido received FDA approval as the first treatment for adults with symptomatic dermographism (SD), the most common form of chronic inducible urticaria.⁵ 

About the REMODEL trials
REMODEL-1/-2 are identical multicenter, randomized, double-blind, active comparator-controlled Phase III studies evaluating the efficacy and safety of remibrutinib compared to teriflunomide for adult patients with relapsing multiple sclerosis (RMS). Approximately 2,000 patients globally with evidence of recent disease activity and an Expanded Disability Status Scale (EDSS) of 0.0–5.5 were randomized 1:1 to receive remibrutinib 100 mg or teriflunomide. The studies consist of an initial double-blind Core Part with a flexible duration of up to a maximum of 30 months, followed by an open-label extension for up to 5 years. The primary endpoint is annualized relapse rate (ARR). Key secondary endpoints include 3- and 6-month confirmed disability progression, the number of new/enlarging T2 lesions per year, the number of Gd+ T1 lesions per scan, serum neurofilament light chain (sNfL) concentration, and the percentage of participants with no evidence of disease activity (NEDA-3).²¹˒²²˒²⁸ 

About Novartis in Neuroscience
Neurological diseases are deeply personal, affecting people of any age, from newborns to seniors, often striking in the prime of life. In multiple sclerosis (MS), Novartis has helped shape the treatment landscape for decades through scientific innovation and leadership in advancing care for people living with MS. We remain focused on addressing unmet needs and pursuing new approaches that may improve outcomes for people across the MS journey. Building on this foundation, we are doubling down on our commitment to neurology, expanding our legacy of innovation in MS and spinal muscular atrophy (SMA) to work in neuroimmunology, neurodegeneration, and neuromuscular diseases. Our goal is to protect people’s health across their lifespan, developing more treatment options that lead to better outcomes.

Disclaimer
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About Novartis
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References 

Comprehensive disease control defined by Phase 3 REMODEL-1/-2 efficacy results presented at MSToronto2026 and Novartis data on file

¹Wiendl, H et al. Efficacy and safety of remibrutinib vs. teriflunomide in relapsing multiple sclerosis: results of the Phase 3 REMODEL-1/-2 trials. Presentation at: MSToronto 2026 Medical Congress; October 23, 2026; Toronto, Ontario, Canada.
²Nuesslein-Hildesheim B, Ferrero E, Schmid C, et al. Remibrutinib (LOU064) inhibits neuroinflammation driven by B cells and myeloid cells in preclinical models of multiple sclerosis. J Neuroinflammation. 2023;20(1):194. Published 2023 Aug 26. doi:10.1186/s12974-023-02877-9
³Metz M, Giménez-Arnau AM, Hide M, et al. Remibrutinib in chronic spontaneous urticaria. N Engl J Med. 2025;392(10):984-994. doi:10.1056/NEJMoa2408792 
⁴Giménez-Arnau AM, Szalewski R, Hide M, et al. Remibrutinib in chronic spontaneous urticaria: 52-week results from two phase 3 studies. J Allergy Clin Immunol. 2026;157(1):143-154. doi:10.1016/j.jaci.2025.09.028 
⁵Novartis. Novartis Rhapsido® (remibrutinib) receives FDA approval as first treatment for symptomatic dermographism (SD), expanding its use beyond chronic spontaneous urticaria (CSU). News release. Novartis. October 7, 2026. Available from: https://www.novartis.com/news/media-releases/novartis-rhapsido-remibrutinib-receives-fda-approval-first-treatment-symptomatic-dermographism-sd-expanding-its-use-beyond-chronic-spontaneous-urticaria-csu Last accessed: October 19, 2026
⁶ Angst D, Gessier F, Janser P, et al. Discovery of LOU064 (Remibrutinib), a Potent and Highly Selective Covalent Inhibitor of Bruton's Tyrosine Kinase. J Med Chem. 2020;63(10):5102-5118. doi:10.1021/acs.jmedchem.9b01916 
⁷Kaul M, End P, Cabanski M, et al. Remibrutinib (LOU064): A selective potent oral BTK inhibitor with promising clinical safety and pharmacodynamics in a randomized phase I trial. Clin Transl Sci. 2021;14(5):1756-1768. doi:10.1111/cts.13005 
⁸Wiendl H, Bermel R, Airas L, et al. Remibrutinib versus teriflunomide in relapsing multiple sclerosis (REMODEL-1 and REMODEL-2): two randomised, phase 3 trials. Lancet 2026; published online Oct 23 
⁹Lambe J, Fox RJ. Bruton's Tyrosine Kinase Inhibitors in Multiple Sclerosis. Drugs. 2026 Jul;86(7):989-1012. doi: 10.1007/s40265-026-02324-y. Epub 2026 May 13. PMID: 42126690; PMCID: PMC13290806
¹⁰Polman CH, O'Connor PW, Havrdova E, et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006;354(9):899-910. doi:10.1056/NEJMoa044397
¹¹Maxwell CR, Turner TJ, Wallstroem E, et al. Tolebrutinib liver safety: A detailed overview. Mult Scler Relat Disord. 2026;113:107404. doi:10.1016/j.msard.2026.107404
¹²O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365(14):1293-1303. doi:10.1056/NEJMoa1014656
¹³Arnold DL, Elliott C, Martin EC, Hyvert Y, Tomic D, Montalban X. Effect of Evobrutinib on Slowly Expanding Lesion Volume in Relapsing Multiple Sclerosis: A Post Hoc Analysis of a Phase 2 Trial. Neurology. 2024;102(5):e208058. doi:10.1212/WNL.0000000000208058
¹⁴Jain RW, Rayatpour A, Hagen K, et al. Investigations of remibrutinib in models pertinent to multiple sclerosis. Neurotherapeutics. 2026;23(3):e00923. doi:10.1016/j.neurot.2026.e00923 
¹⁵Pulz R, Angst D, Cenni B. Next generation Bruton's tyrosine kinase inhibitors - characterization of in vitro potency and selectivity. Eur J Pharmacol. 2025;1002:177747. doi:10.1016/j.ejphar.2025.177747
¹⁶Novartis. Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU). Novartis US. Published February 18, 2026. Available from: https://www.novartis.com/us-en/news/media-releases/novartis-remibrutinib-first-therapy-achieve-phase-iii-primary-endpoint-chronic-inducible-urticaria-cindu Last accessed: October 19, 2026
¹⁷Ferreira HB, Neves B, Guerra IM, Moreira A, Melo T, Paiva A, Domingues MR. An overview of lipidomic analysis in different human matrices of multiple sclerosis. Mult Scler Relat Disord. 2020;44:102189. doi:10.1016/j.msard.2020.102189  
¹⁸Portaccio E, Magyari M, Kubala Havrdova E, et al. Multiple sclerosis: emerging epidemiological trends and redefining the clinical course. Lancet Reg. Health Eur. 2024;44:100977 
¹⁹National Multiple Sclerosis Society. Types of MS. Available from: https://www.nationalmssociety.org/What-is-MS/Types-of-MS Last accessed: October 19, 2026
²⁰Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014;83(3):278-286. doi:10.1212/WNL.0000000000000560 
²¹ClinicalTrials.gov. NCT05147220. Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis (RMS) (REMODEL-1). Available from: https://clinicaltrials.gov/study/NCT05147220 Last accessed: October 19, 2026 
²²ClinicalTrials.gov. NCT05156281. Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis (RMS) (REMODEL-2). Available from: https://clinicaltrials.gov/study/NCT05156281 Last accessed: October 19, 2026 
²³ClinicalTrials.gov. NCT07225504. A study to evaluate the efficacy and safety of remibrutinib in secondary progressive multiple sclerosis (REMASTER). Available from: https://clinicaltrials.gov/study/NCT07225504 Last accessed: October 19, 2026 
²⁴ClinicalTrials.gov. NCT03827798. Study of efficacy and safety of investigational treatments in patients with moderate to severe hidradenitis suppurativa. Available from: https://clinicaltrials.gov/ct2/show/NCT03827798. Last accessed: October 19, 2026 
²⁵ClinicalTrials.gov. NCT05432388. Study of efficacy, safety and tolerability of remibrutinib in adult participants with an allergy to peanuts. Available from: https://clinicaltrials.gov/study/NCT05432388 Last accessed: October 19, 2026
²⁶Novartis. Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU). News release. Novartis. September 30, 2025. Available from: https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu Last accessed: October 19, 2026 
²⁷Novartis. Novartis Rhapsido® receives European Commission approval as first oral targeted treatment for chronic spontaneous urticaria. News release. Novartis. April 27, 2026. Available from: https://www.novartis.com/news/media-releases/novartis-rhapsido-receives-european-commission-approval-first-oral-targeted-treatment-chronic-spontaneous-urticaria Last accessed: October 19, 2026 
²⁸Wiendl H, Airas L, Chitnis T, et al. Phase 3 REMODEL I/II Trials: Efficacy, Safety, and Tolerability of Remibrutinib in Patients with Relapsing Multiple Sclerosis. Mult Scler Relat Disord. 2023;80:105315. doi:10.1016/j.msard.2023.105315 
  
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