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Novartis announced positive topline results from its Phase III REMODEL-1/-2 trials for remibrutinib, an oral BTK…
NVSNovartis AG
Novartis announced positive topline results from its Phase III REMODEL-1/-2 trials for remibrutinib, an oral BTK inhibitor, in patients with relapsing multiple sclerosis (RMS). The trials met their primary endpoint, demonstrating significant superiority over teriflunomide in reducing the annualized relapse rate and inflammatory brain lesions. Remibrutinib also showed clinically meaningful reductions in disability progression endpoints, including a positive trend in 3-month confirmed disability progression and nominally significant results for 6-month confirmed disability progression in a combined analysis. The drug exhibited a favorable safety profile with no liver safety signals across more than 4,500 clinical trial participants. Novartis plans to present this data at MSToronto2026 and intends to submit regulatory applications globally for remibrutinib in RMS. Novartis is an innovative medicines company developing pharmaceuticals to treat serious diseases.