Novartis presented the REMODEL-1 and REMODEL-2 results at the MSToronto2026 congress on Friday, reporting annualized relapse rates of 0.073 and 0.080 on remibrutinib against 0.112 and 0.116 on teriflunomide, Sanofi’s Aubagio, in about 2,000 patients with relapsing multiple sclerosis. MRI activity fell sharply, with T2 lesion activity down 65 percent and 70 percent across the two trials and gadolinium-enhancing T1 lesions down 66 percent, and more than 92 percent of remibrutinib patients remained free from six-month confirmed disability progression over 24 months. No liver safety signal appeared, including no Hy’s Law cases, liver enzyme elevations above three times the upper limit of normal occurred in 2.0 percent of remibrutinib patients against 7.4 percent on teriflunomide, and Novartis said it plans to seek regulatory approval for relapsing multiple sclerosis globally.
Novartis MS drug cuts relapses by a third in trials
Novartis's oral drug remibrutinib cut the annualized relapse rate by 35.2 percent and 31.2 percent against teriflunomide in the two Phase 3 REMODEL trials in relapsing multiple sclerosis, to about one relapse every 13 years, the company said on Friday.
Why it matters: With no liver safety signal, the side effect that has hurt rival BTK inhibitors, and a near 30 percent delay in confirmed disability progression, remibrutinib gives Novartis a credible entrant in relapsing MS if regulators accept the data, though Roche's fenebrutinib cut relapses by more than half in its own trials.
Data as of Novartis media release of October 23, 2026, read in full; all trial figures are the sponsor's own, presented at MSToronto2026 and published simultaneously in The Lancet. STAT report of October 23, 2026, read to its subscription break, supplied the comparison with Roche's fenebrutinib. Developing item.