EMA accepts MAA for filgotinib to treat rheumatoid arthritis

Gilead Sciences, Inc. and Galapagos NV announced that the Marketing Authorization Application (MAA) for filgotinib , an investigational, oral, selective JAK1 inhibitor, for the treatment of adults with rheumatoid arthritis (RA) has been validated and is now under evaluation by the European Medicines Agency (EMA)

The MAA for filgotinib is supported by 24-week data from the Phase III FINCH clinical trials in which once-daily treatment with filgotinib achieved improvements in clinical signs and symptoms, achievement of low disease activity and remission, and inhibition of structural damage for different sub-populations of patients living with RA. Across the FINCH program, safety data were consistent with previously reported results.