Efficacy and safety results of filgotinib through 52 weeks in FINCH 1 and FINCH 3 studies in rheumatoid arthritis.- Gilead Sciences + Galapagos NV

Gilead Sciences, Inc. and Galapagos NV announced that Week 52 data from the registrational Phase III FINCH 1 and FINCH 3 trials of filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of moderately-to-severely active rheumatoid arthritis (RA) are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier this year.Detailed Week 52 results from the FINCH 1 and 3 trials will be submitted for presentation at a future medical conference.

A Marketing Authorization Application (MAA) for filgotinib for the treatment of adults with rheumatoid arthritis is now under evaluation by the European Medicines Agency (EMA) and a New Drug Application (NDA) for filgotinib has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW). Gilead plans to file a New Drug Application (NDA) for filgotinib for the treatment of rheumatoid arthritis in the United States including the FINCH 1 and FINCH 3 Week 52 data later this year.