FDA Grants Priority Review to Genentech's Fenebrutinib for Relapsing and Primary Progressive MS

Genentech, a unit of Roche Holding AG (RHHBY, RO.SW), said the U.S. Food and Drug Administration accepted its New Drug Application under priority review for fenebrutinib in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The filing is the first FDA acceptance for a BTK inhibitor in both indications. The submission is based on Phase III FENhance 1 and 2 RMS trials and the Phase III FENtrepid PPMS study. Fenebrutinib reduced relapses by 51% and 58% versus teriflunomide in the RMS trials, with a consistent positive trend in delaying disability. If approved, fenebrutinib would become the first BTK inhibitor and first high-efficacy oral treatment for both RMS and PPMS. Chief Medical Officer Levi Garraway said three Phase III studies support its potential across the MS spectrum.