Novartis’ BTK inhibitor remibrutinib cuts MS relapse rates in Phase 3, setting up FDA filing

Novartis reported that its BTK inhibitor remibrutinib, already approved for chronic spontaneous urticaria, lowered annualized relapse rates in two Phase 3 studies of relapsing multiple sclerosis when compared with the active control teriflunomide.

The trials, REMODEL-1 and REMODEL-2, also showed stronger reductions in inflammatory brain lesions and improvements in disability progression at three and six months, based on a pooled analysis. Specific efficacy numbers were not disclosed.

Based on these positive topline results, Novartis plans to seek an expanded FDA indication for remibrutinib in relapsing MS next year. The data position the drug against Roche’s BTK inhibitor fenebrutinib, which is also nearing market entry.