Roche files fenebrutinib NDA for relapsing and primary progressive MS
Roche's investigational non-covalent BTK inhibitor fenebrutinib has had its NDA accepted by the FDA for priority review, based on data from phase 3 FENhance 1 and 2 in relapsing MS and FENtrepid in primary progressive MS. In FENhance trials fenebrutinib cut relapses by 51% and 58% versus teriflunomide and showed a consistent trend delaying disability; FENtrepid was the first phase 3 PPMS trial in over a decade to slow disability progression with a numerical benefit versus Ocrevus. If approved, it would offer the first BTK inhibitor and a high-efficacy oral option for RMS and PPMS.
Fenebrutinib could become the first oral high-efficacy BTK option for MS
Context
Roche submitted a New Drug Application for fenebrutinib backed by three phase 3 trials.…
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