Novartis reports Phase 3 trial data showing remibrutinib cuts relapse rates in relapsing MS
Novartis announced that its BTK inhibitor remibrutinib lowered annualised relapse rates by 35.2% in the REMODEL‑1 trial and by 31.2% in the REMODEL‑2 trial versus teriflunomide. The studies also showed more than 92% of patients remained free from six‑month confirmed disability progression over a 24‑month period and no Hy’s Law liver‑injury cases were observed. The results were presented at MSToronto2026 and will support global regulatory submissions for the drug.
Why it matters
The company said the data reinforce confidence in remibrutinib and its potential to expand treatment options for relapsing multiple sclerosis, which could generate future revenue if approved. Shares in Novartis fell after the announcement.
Key facts
- 1Remibrutinib reduced annualised relapse rates by 35.2% in REMODEL‑1 (0.073 vs 0.112 per patient‑year). finance.yahoo.com
- 2Remibrutinib reduced annualised relapse rates by 31.2% in REMODEL‑2 (0.080 vs 0.116 per patient‑year). finance.yahoo.com
- 3More than 92% of patients on remibrutinib remained free from six‑month confirmed disability progression during the 24‑month observation period. finance.yahoo.com
- 4No Hy’s Law liver‑injury cases were reported among remibrutinib‑treated patients. finance.yahoo.com
- 5Novartis plans to seek global regulatory approval for remibrutinib in relapsing multiple sclerosis. pmlive.com
- 6Novartis shares declined on the day the results were released. finance.yahoo.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.