Novartis's remibrutinib cuts relapses versus teriflunomide in two pivotal MS trials
- The REMODEL-1 and REMODEL-2 Phase 3 trials compared oral BTK inhibitor remibrutinib with teriflunomide in relapsing multiple sclerosis.
- Both met the primary endpoint of lower annualized relapse rate, and MRI lesion measures also favored remibrutinib.
- Novartis reported no liver safety signal and a positive trend on disability progression, and plans regulatory submissions.
💡 Points
The BTK class has been hurt in MS by liver-safety worries, so a clean liver profile is as important as the relapse benefit. Teriflunomide is an easy comparator, though, and the real contest is against high-efficacy anti-CD20 antibodies and other BTK inhibitors such as Sanofi's tolebrutinib; disability data will decide where remibrutinib fits.
STAT+: Novartis multiple sclerosis treatment cuts rates of relapse in pivotal trials ↗