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Novartis remibrutinib succeeds in MS trials
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Novartis remibrutinib succeeds in MS trials

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  • Novartis reported positive Phase 3 REMODEL-1 and REMODEL-2 results for remibrutinib in relapsing multiple sclerosis.
  • The oral BTK inhibitor reduced annualized relapse rates and MRI lesions compared with teriflunomide.
  • Novartis plans to present trial data and submit remibrutinib for regulatory review globally.

Novartis (NYSE:NVS) reported positive Phase 3 REMODEL-1 and REMODEL-2 trial results showing remibrutinib reduced annualized relapse rates compared with teriflunomide in adults with relapsing multiple sclerosis.

The trials met their primary endpoint and showed superiority of remibrutinib across key secondary measures, including reductions in inflammatory brain lesions observed through MRI assessments.

“Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention, slow disability progression, while maintaining a favorable safety profile,” said Shreeram Aradhye, President, Development, and Chief Medical Officer of Novartis.

The Phase 3 studies evaluated approximately 2,000 patients globally and found a positive trend in 3-month confirmed disability progression and nominal statistical significance in 6-month confirmed disability progression in a combined analysis of both trials.

Novartis reported that remibrutinib maintained a favorable safety profile with no liver safety signal.

Novartis develops pharmaceutical treatments across multiple areas, including neuroscience, immunology, oncology, and cardiovascular medicine.

The company said it plans to present REMODEL-1 and REMODEL-2 data at MSToronto2026 and seek regulatory approval for remibrutinib in relapsing multiple sclerosis markets globally.

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