Roche's Fenebrutinib Receives U.S. FDA Priority Review for Relapsing and Primary Progressive Multiple Sclerosis

The U.S. Food and Drug Administration (FDA) has accepted Roche's New Drug Application (NDA) for fenebrutinib, an investigational non-covalent Bruton's tyrosine kinase (BTK) inhibitor, under priority review for treating both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This marks a significant regulatory step for a potential new oral treatment that aims to address both acute inflammation and chronic brain inflammation in MS, a disease with limited options, especially for PPMS. The filing is based on data from comprehensive Phase III clinical trials.