Novartis MS drug remibrutinib meets Phase III trial goals

Novartis (NYSE: NVS) announced positive topline results from its Phase III REMODEL-1 and REMODEL-2 trials evaluating remibrutinib in relapsing multiple sclerosis (RMS).

Remibrutinib, an oral Bruton's tyrosine kinase (BTK) inhibitor, demonstrated superiority over teriflunomide in reducing annualized relapse rate (ARR) and inflammatory brain lesions across both trials in adults with RMS.

In key secondary endpoints, remibrutinib showed reductions versus teriflunomide related to disability progression, with a positive trend in 3-month confirmed disability progression and nominal significance in 6-month confirmed disability progression in a preplanned combined analysis of both trials.

The safety profile was consistent with the broader remibrutinib development program, which includes more than 4,500 clinical trial participants across multiple indications. No liver safety signal was observed, including no cases meeting Hy's Law criteria.

"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 of Development and Chief Medical Officer at Novartis.

Novartis plans to present the REMODEL-1 and REMODEL-2 data as a late-breaker at MSToronto2026 and intends to host an investor call following the presentation. The company also stated it plans to seek regulatory approval for remibrutinib in RMS globally.

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