The oral BTK inhibitor remibrutinib met the primary goal of the Phase III REMODEL-1/-2 studies, lowering the annualized relapse rate against teriflunomide (Aubagio) in relapsing multiple sclerosis. It also beat the comparator on all key secondary endpoints with a favorable safety profile and no liver signal. Novartis will file for approval globally after presenting the data at MSToronto2026.
Novartis' remibrutinib cut annualized relapse rates versus teriflunomide (Aubagio) in two Phase III relapsing multiple sclerosis trials, the company said.
"Building on our long-standing commitment to advancing care in MS, these findings reinforce our continued ambition on driving innovation in this space," Shreeram Aradhye, president of development and chief medical officer at Novartis, said.
The REMODEL-1/-2 studies randomized about 2,000 adults with recent disease activity and an Expanded Disability Status Scale score of 0.0 to 5.5 to remibrutinib 100 mg or teriflunomide at a 1:1 ratio. Remibrutinib showed superiority on all key secondary endpoints within each trial, including fewer new or enlarging T2 lesions and Gd+ T1 lesions, and delivered a clinically meaningful delay in 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.
The drug showed a favorable safety profile with no liver safety signal and no cases meeting Hy's Law criteria, consistent with a development program spanning more than 4,500 participants. Novartis plans to present the data as a late-breaker at MSToronto2026 and to seek regulatory approval for remibrutinib in RMS globally.
Remibrutinib is a highly selective oral Bruton's tyrosine kinase inhibitor that blocks the BTK pathway, curbing activation of B cells and innate immune cells to dampen neuroinflammation. Relapsing MS is the most common form of the disease, which affects nearly 3 million people worldwide. The trials' core phase runs up to 30 months, followed by an open-label extension of up to five years, with secondary measures including serum neurofilament light chain concentration and no-evidence-of-disease-activity status.
Teriflunomide, sold as Aubagio, is an established once-daily oral disease-modifying therapy for relapsing forms of MS. The readout marks a second indication for remibrutinib, already approved as Rhapsido by the US Food and Drug Administration in September 2025 and the European Medicines Agency in April 2026 for chronic spontaneous urticaria. Novartis is also testing the drug in secondary progressive MS under the REMASTER program and in hidradenitis suppurativa and food allergy.
The results position remibrutinib as a potential high-efficacy oral option in an MS market where patients weigh convenience against relapse control. Investors will watch the MSToronto2026 presentation and the timing of global filings, which could broaden Novartis' neuroscience franchise beyond its existing MS portfolio.
This article is for informational purposes only and does not constitute investment advice.
