FDA Accepts Roche's Fenebrutinib NDA Under Priority Review For Relapsing And Primary Progressive MS, Backed By Phase III Data Showing 51.1%, 58.5% Relapse Reductions Vs Teriflunomide
Fenebrutinib cut relapses by 51% and 58% vs teriflunomide in Phase III RMS trials (FENhance 1 & 2) while showing a consistent, positive trend in delaying disability1
Fenebrutinib became the first investigational medicine in more than a decade to slow disability progression in a Phase III PPMS trial (FENtrepid), with numerical benefit vs Ocrevus2
Fenebrutinib is designed to address two drivers of MS – acute inflammation causing relapses and chronic brain inflammation driving disability progression1,2
If approved, fenebrutinib would become the first BTK inhibitor and first high-efficacy oral treatment for both RMS and PPMS, offering a new option for the nearly 1 million Americans living with MS3
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