Novartis said its oral BTK inhibitor remibrutinib—marketed as Rhapsido—met the primary endpoint in both Phase 3 REMODEL-1 and REMODEL-2 trials in adults with relapsing multiple sclerosis.
Compared with teriflunomide (Aubagio), remibrutinib significantly reduced annualized relapse rates and inflammatory MRI brain lesions.
A pooled analysis showed a clinically meaningful delay in disability progression:
a positive trend in three-month confirmed progression and nominal statistical significance at six months. Novartis did not disclose detailed numerical results.
The trials enrolled approximately 2,000 patients. Novartis plans to seek expanded approval for relapsing MS, potentially by 2027.
The results set up competition with Roche’s fenebrutinib, another oral BTK inhibitor in development for MS. Both programs have shown signals of slowing disability progression, although cross-trial comparisons are not appropriate.
Novartis highlighted a favorable safety profile, including no cases meeting Hy’s Law criteria for severe drug-induced liver injury in the REMODEL studies—a notable differentiator because liver toxicity has affected some BTK inhibitors.
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