Novartis AGPositive Phase III results for remibrutinib in RMS, showing efficacy and safety, supporting regulatory approval.

Novartis announced positive topline results from its Phase III REMODEL-1 and REMODEL-2 trials, showing that remibrutinib, an oral BTK inhibitor, significantly reduced annualized relapse rate versus teriflunomide in patients with relapsing multiple sclerosis. The trials met their primary endpoint and demonstrated superiority on all key secondary endpoints, including reductions in MRI lesions and a clinically meaningful delay in disability progression. Remibrutinib showed a favorable safety profile with no liver safety signal, consistent with its use in chronic spontaneous urticaria. Novartis plans to present the data at MSToronto2026 and intends to seek regulatory approval globally.
Novartis AGPositive Phase III results for remibrutinib in RMS, showing efficacy and safety, supporting regulatory approval.