Roche Reports Phase 3 Results for Fenebrutinib in Rheumatoid Arthritis

Roche today announced results from the Phase 3 FENoRA trial evaluating fenebrutinib, a non-covalent BTK inhibitor, in patients with moderately to severely active rheumatoid arthritis who had inadequate response to methotrexate. Fenebrutinib demonstrated a statistically significant improvement in ACR20 response rate at week 12 compared to placebo. The safety profile was manageable with no new safety signals identified. These results support fenebrutinib as a potential new treatment option for RA patients and Roche plans to submit for regulatory approval.