Novartis cuts multiple sclerosis relapses by 35.2% in one trial and 31.2% in another
Key Facts
On October 23, 2026, Novartis announced positive full results from the REMODEL-1 and REMODEL-2 phase III trials of oral remibrutinib for relapsing multiple sclerosis, with the drug meeting the primary endpoint in both and reducing the annualized relapse rate versus teriflunomide. The rate was 0.073 relapses per year with remibrutinib versus 0.112 with the comparator in REMODEL-1, equivalent to a relative reduction of 35.2%. In REMODEL-2, the rate was 0.080 versus 0.116 relapses per year, a relative reduction of 31.2%. The company said both reductions were statistically significant and clinically meaningful. These results correct the earlier draft’s description of them as disappointing or below investor expectations; the official announcement describes both trials as positive.
The announced results also included measures of disability progression in a prespecified pooled analysis of the two trials. Treatment was associated with a nominal 29.2% reduction in the risk of disability progression confirmed over six months, while the measure of progression confirmed over three months showed a consistent trend toward a reduction of 20.5%. Novartis said more than 92% of patients who received remibrutinib remained free of disability progression by the six-month measure through 24 months. Neurology professor Heinz Wiendl said the results showed "a meaningful reduction in relapse activity, with a clinically meaningful effect on confirmed disability progression." He added that multiple sclerosis treatment goals extend beyond relapse control alone, pointing to the importance of considering the measures together when evaluating treatment results.
In another pooled analysis, 55.0% of patients receiving remibrutinib achieved no disease activity across three areas—relapses, disability progression and MRI activity—compared with 32.1% of patients receiving teriflunomide. This measure combines different aspects of disease activity, alongside the annualized relapse rate that served as the trials’ primary endpoint. The comparison places the composite result alongside relapse and disability measures, rather than limiting the drug’s evaluation to relapse counts alone. The company said the trial data therefore showed disease control across these three areas. These results remain part of the clinical data package the company intends to use in its regulatory process.
On safety, neither trial recorded cases meeting Hy’s Law criteria. The proportion of patients whose ALT levels rose above three times the upper limit of normal was 2.0% with remibrutinib, versus 7.4% with teriflunomide. In the pooled analysis, 3.1% discontinued treatment because of adverse events with remibrutinib, compared with 5.8% with the comparator. These figures provide a direct comparison between the treatment arms on two measures related to liver safety and treatment continuation. Novartis said discontinuations due to adverse events were about half as frequent with remibrutinib, consistent with its overall description of the profile as favorable.
The trials included about 2,000 patients worldwide, randomly assigned in a 1:1 ratio to remibrutinib at a dose of 100 mg or teriflunomide. The design comprised a double-blind core period of flexible duration, lasting up to 30 months, followed by an open-label extension phase of up to five years. The full announcement followed an initial announcement on September 1, 2026, when Novartis said both trials had met their primary endpoint of reducing the annualized relapse rate. The company then pointed to plans to present the data at MSToronto2026 and submit them to health authorities globally. The number of participants and follow-up period provide context for reading the reported results, while regulatory approval remains a separate step from trial success.
Novartis said it intends to seek regulatory approvals for remibrutinib to treat relapsing multiple sclerosis in markets worldwide. The announcement did not specify when applications would be filed or when regulators would issue decisions. In trading on October 23, the company’s American depositary receipts fell by as much as 4.5% around midday before partially recovering, according to Dow Jones. Dow Jones reported that the relative reduction in the relapse rate in the two trials was smaller than the reduction achieved by a competing Roche drug. Novartis shares closed at $156.27 on October 22, according to EL7 data, before trading on the announcement day; that prior close alone does not establish the cause of the subsequent share move.