Roche's Fenebrutinib Receives FDA Priority Review for Multiple Sclerosis

The U.S. Food and Drug Administration (FDA) has accepted Roche's New Drug Application (NDA) for fenebrutinib, an investigational oral Bruton's tyrosine kinase (BTK) inhibitor, under priority review for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This filing is based on data from Phase III clinical trials (FENhance 1 and 2 for RMS, and FENtrepid for PPMS), suggesting fenebrutinib's potential to address both relapse control and disability progression. If approved, it would be the first BTK inhibitor and a high-efficacy oral treatment for both forms of MS.