Launch Catch-Up — Results Announced October 23, 2026
Novartis said remibrutinib reduced relapses compared with teriflunomide in two late-stage studies involving approximately 2,000 adults with relapsing multiple sclerosis.
In REMODEL-1, annualized relapse rates were 0.073 with remibrutinib and 0.112 with the comparison treatment. In REMODEL-2, they were 0.080 and 0.116. The company reported relative reductions of 35.2% and 31.2%, respectively.
The randomized, double-blind trials used relapse rate as their primary endpoint. A pooled disability-progression finding had nominal statistical significance, a qualification that limits how firmly that result can be interpreted.
Serious adverse events occurred in 6.0% of remibrutinib recipients and 7.0% of those receiving teriflunomide. Two deaths in the remibrutinib group were assessed by investigators as unrelated to treatment, Novartis said.
Novartis plans to seek regulatory approval for the MS use. The company’s announcement reports trial findings, rather than an authorization to prescribe remibrutinib for MS.
Sources: Novartis, October 23 trial announcement: https://www.novartis.com/news/media-releases/novartis-remibrutinib-delivered-comprehensive-disease-control-phase-iii-rms-trials-proven-robust-safety-profile