Novartis reports strong Phase III results for BTK inhibitor remibrutinib in relapsing MS
Novartis announced that its oral BTK inhibitor remibrutinib cut the annualized relapse rate by 35.2% in one Phase III trial and 31.2% in a second trial versus teriflunomide. The drug also lowered the risk of 6‑month confirmed disability progression by 29.2% and showed no liver safety signal. Results were presented at the MSToronto2026 conference and published in The Lancet, and the company said it will seek global regulatory approval.
Why it matters
The data give Novartis a potential new therapy in the large relapsing‑multiple‑sclerosis market, creating a future revenue catalyst if regulators approve the drug. The favorable safety profile may aid payer acceptance and market uptake.
Key facts
- 1Remibrutinib reduced the annualized relapse rate by 35.2% in the REMODEL‑1 trial and 31.2% in the REMODEL‑2 trial versus teriflunomide. tradingview.com
- 2The drug lowered the risk of 6‑month confirmed disability progression by 29.2% (nominal significance). tipranks.com
- 3More than 92% of patients on remibrutinib remained free from disease progression over 24 months as assessed by 6‑month CDP. finanznachrichten.de
- 4No liver safety signal was observed; ALT >3×ULN occurred in 2.0% of remibrutinib patients versus 7.4% of teriflunomide patients. finanznachrichten.de
- 5Treatment discontinuations due to adverse events were 3.1% with remibrutinib versus 5.8% with teriflunomide. finanznachrichten.de
- 6Results were presented at the MSToronto2026 (10th Joint ACTRIMS‑ECTRIMS) meeting and published in The Lancet. tipranks.com
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.