Novartis presents full remibrutinib trial data in relapsing multiple sclerosis

Novartis also reports no liver safety signal in the two trials, and two deaths that its investigators judged unrelated to treatment.

Novartis presented full results from two Phase 3 trials of remibrutinib in relapsing multiple sclerosis (RMS) on Oct 23, at the MSToronto2026 meeting. The results were published at the same time in The Lancet. Novartis first announced the topline result on Sept 1, 2026: both trials met their primary endpoint, a significant cut in annualized relapse rate.

They compare remibrutinib 100 mg with teriflunomide, Sanofi's Aubagio, for up to 30 months, followed by a 5-year extension. Novartis reports that remibrutinib cut relapses against teriflunomide to about 1 relapse every 13 years. It reports that T2 lesion activity fell by 65% and 70% in the two trials, and that gadolinium-enhancing T1 lesions fell by 66% across both. Over 92% of remibrutinib patients were free from 6-month confirmed disability progression, which Novartis puts at a delay of nearly 30% against teriflunomide. That difference was nominally significant.

Novartis reports no liver safety signal and no cases of Hy's Law, a marker for serious drug-induced liver injury. It reports two deaths in the remibrutinib group, which investigators judged unrelated to treatment.

Remibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor, and Novartis is betting on it as a successor to its older MS therapies, which face generic competition. Relapsing MS would be a third possible use, after urticaria and Sjogren's disease. Positive data puts remibrutinib in more direct contention with established oral MS drugs, a much larger and more competitive market than urticaria. Novartis said on Sept 1 that it plans to submit the data to health authorities. A Kisqali listing in Canada on Oct 23 is one of several incremental wins Novartis has booked this month, and this MS result adds to that pattern on the neurology side.