Roche said the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for fenebrutinib and granted it priority review. The application seeks approval to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Fenebrutinib is the first investigational Bruton's tyrosine kinase (BTK) inhibitor accepted for review for both forms of the disease.
The submission is supported by positive results from three Phase III studies: FENhance 1, FENhance 2 and FENtrepid. In the RMS trials, fenebrutinib reduced relapse rates by more than 50% compared with teriflunomide, the standard of care. In PPMS, the drug showed a positive trend in delaying disability progression.
If approved, fenebrutinib would be the first high-efficacy oral therapy for both major types of MS and could offer patients a new treatment option.