Novartis cuts multiple sclerosis relapses 35.2% and 31.2% in two trials
Key Facts
Novartis announced positive results on 23 October 2026 from the phase III REMODEL-1 and REMODEL-2 trials of remibrutinib in patients with relapsing multiple sclerosis, with the findings published simultaneously in The Lancet. The trials compared the drug with teriflunomide and showed a lower annualized relapse rate in both. The rate was 0.073 relapses per patient per year with remibrutinib, versus 0.112 with teriflunomide in REMODEL-1. In REMODEL-2, the rate was 0.080 versus 0.116. The company said this represented relative reductions of 35.2% and 31.2%, respectively, and described the effect as statistically significant and clinically meaningful.
The trials included 2,007 patients who were randomly assigned, providing the patient base on which the reported findings were based. REMODEL-1 included 1,000 patients, while REMODEL-2 included 1,007 patients. Lower relapse rates with remibrutinib were seen in each trial separately, with teriflunomide used as the comparator in both. The results presentation showed relative reductions of 35.2% in the first trial and 31.2% in the second. The findings from both trials were published simultaneously with Novartis’ announcement, according to the company statement and the data published in The Lancet.
The reported findings extended to magnetic resonance imaging measures, with remibrutinib reducing T2 lesion activity by 65% in REMODEL-1 and 70% in REMODEL-2 compared with teriflunomide. The trials also showed a 66% reduction in Gd+ T1 lesions. These measures place the relapse findings within a set of metrics the company presented to assess disease activity. The imaging measures compared the same two treatments used in the trials. Novartis said the findings were part of the disease control demonstrated by the phase III data.
In a prespecified pooled analysis of the two trials, remibrutinib reduced the risk of confirmed disability progression over six months by 29.2%, with nominal significance. The analysis also showed a positive trend, with a 20.5% reduction in confirmed disability progression over three months. The company said more than 92% of patients who received remibrutinib remained free of disability progression on the six-month measure over 24 months. These measures add a time dimension to the relapse and imaging findings by tracking disability progression over three- and six-month periods. The company statement described the reduction on the six-month measure as nominally significant, the wording it used when presenting the analysis result.
On liver safety, Novartis said the trials detected no liver safety signal or cases meeting Hy’s Law criteria. ALT levels above three times the upper limit of normal were recorded in 2.0% of patients receiving remibrutinib, versus 7.4% of those receiving teriflunomide. These rates place the safety result in a direct comparison between the treatment groups in the trials. Liver safety concerns were described in the initial draft as a concern for this class of drugs, while the company statement presented the monitoring findings and recorded rates specifically. These results remain part of the phase III data announced by the company, not a judgment on the drug’s approval or therapeutic use.
The results come as Roche has presented data on fenebrutinib, an investigational drug for relapsing multiple sclerosis. In April 2026, Roche said fenebrutinib reduced the annualized relapse rate compared with teriflunomide by 51.1% in FENhance 1 and 58.5% in FENhance 2 over 96 weeks. In October 2026, the company said pooled data from the trials showed a 55% reduction versus the comparator treatment. These figures place the published remibrutinib results in the context of a research race in which both companies use teriflunomide as a comparator. The reported reductions differ across trial programs, with each set of findings tied to its specific trials and periods.
Novartis said it plans to seek global regulatory approvals for remibrutinib to treat relapsing multiple sclerosis. Its statement did not specify a filing date, and the announced step follows the presentation of results from the two trials and their simultaneous publication in The Lancet. Novartis shares, listed under the ticker NVS, closed at $151.12 on 23 October 2026, according to EL7 data. EL7 data available for that day are limited to the closing price. Seeking regulatory approvals is the next step the company announced after the phase III results.