Novartis presented remibrutinib phase 3 trial results at a Toronto medical congress on October 23, 2026, showing the oral multiple sclerosis drug reduced annualized relapse rates by 35.2% and 31.2% versus teriflunomida, below analyst expectations of 45-60% reduction. Competitor Roche reported 55% reduction for rival drug fenebrutinib days earlier. Analysts estimate remibrutinib could reach peak sales exceeding $4 billion if approved for relapsing MS.
Remibrutinib trial results
- ▪Novartis oral multiple sclerosis drug remibrutinib reduced annualized relapse rates by 35.2% and 31.2% compared to teriflunomida in clinical trials
- ▪Detailed results of remibrutinib's phase 3 trials were presented at a multiple sclerosis medical congress held in Toronto on October 23, 2026
- ▪Analysts expected remibrutinib to achieve a relapse reduction of between 45% and 60% in its phase 3 trials versus teriflunomide
- ▪Teriflunomida is an older multiple sclerosis treatment marketed by Sanofi under the brand name Aubagio
Roche fenebrutinib comparison
- ▪Heinz Wiendl, co-chair of Novartis' REMODEL-1 and REMODEL-2 studies, stated that remibrutinib and fenebrutinib could be quite similar in reducing relapses and disability
- ▪Roche published data on fenebrutinib days before Novartis presented detailed results of remibrutinib's phase 3 trials on October 23, 2026
- ▪Roche reported a 55% reduction in annualized relapse rate versus teriflunomida for its rival multiple sclerosis drug fenebrutinib in pooled phase III data
Anti-CD20 therapy competition
- ▪Anti-CD20 therapies target and destroy immune cells that cause multiple sclerosis
- ▪Analysts indicated that relapse improvements similar to those seen in Roche's fenebrutinib trial would be needed to demonstrate that BTK inhibitors are better than anti-CD20 therapies
- ▪Anti-CD20 therapies currently used for multiple sclerosis include Ocrevus, Novartis Kesimpta, and TG Therapeutics Briumvi
Safety profile differences
- ▪Remibrutinib and fenebrutinib belong to a class of treatments previously associated with liver toxicity
- ▪Novartis stated that no liver safety signals were observed with remibrutinib
- ▪Roche's fenebrutinib showed significantly greater elevations of liver enzymes compared to the reference drug teriflunomide
Novartis commercial outlook
- ▪Analysts currently estimate that remibrutinib could reach peak sales of more than $4 billion if approved for patients with relapsing forms of multiple sclerosis
- ▪Novartis recently experienced setbacks in trials of its heart drug pelacarsen and its muscle weakness treatment del-desiran
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