Novartis said its oral BTK inhibitor remibrutinib, marketed as Rhapsido, met the primary endpoint in both Phase III REMODEL-1 and REMODEL-2 trials in adults with relapsing multiple sclerosis (RMS).
Compared with Sanofi’s teriflunomide (Aubagio), remibrutinib significantly reduced annualized relapse rates and inflammatory MRI brain lesions.
A preplanned combined analysis showed a positive trend in three-month confirmed disability progression and nominal statistical significance at six months, suggesting a potential delay in disability worsening.
The safety profile was favorable, with Novartis reporting no liver-safety signal or cases meeting Hy’s Law criteria in the two studies. Nearly 2,000 patients participated across the trials.
Novartis plans to submit the results to regulators worldwide. Detailed data are expected to be presented later, with reports indicating full results could arrive in October.
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