Novartis announced positive top-line results from its Phase III REMODEL-1 and REMODEL-2 trials for remibrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, in patients with relapsing multiple sclerosis (RMS). The drug met its primary endpoint in both trials, demonstrating superiority over teriflunomide (Sanofi's Aubagio) in significantly reducing the annualized relapse rate (ARR) and inflammatory brain lesions.
Remibrutinib also showed superiority on all key secondary endpoints within each trial and achieved a clinically meaningful delay in disability progression, including a positive trend in 3-month confirmed disability progression (3mCDP) and nominally significant 6-month confirmed disability progression (6mCDP) in a preplanned combined analysis of both trials. The safety profile was favorable and consistent with previous studies, with no liver safety signals reported, including no cases meeting Hy’s Law criteria.
Novartis considers remibrutinib a significant growth driver, with some analysts estimating its potential peak annual sales to be over $10 billion. The company plans to present the detailed data at MSToronto2026 and will submit the results to health authorities globally to seek regulatory authorization for remibrutinib in RMS. The drug is already approved in the U.S. and EU for chronic spontaneous urticaria.
This success is particularly important for Novartis's long-term growth outlook. CEO Vasant Narasimhan previously stated that a positive outcome in these trials for remibrutinib, which he referred to as Rhapsido, would represent a "massive" opportunity. The company remains committed to advancing care in MS and addressing evolving patient needs with high-efficacy oral therapies.
