United States-based Gilead Sciences and Belgium-based Galapagos NV have revealed the Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib, an investigational, oral, selective JAK1 inhibitor, intended for the treatment of moderately-to-severely active rheumatoid arthritis, it was reported on Friday.
The results are consistent with and support the efficacy, safety and tolerability profiles showcased in the Week 12 and 24 analyses revealed earlier this year.
The European Medicines Agency is assessing a Marketing Authorization Application for filgotinib intended for the treatment of adults with rheumatoid arthritis and a New Drug Application for the product has been submitted to the Japanese Ministry of Health, Labour and Welfare.
Detailed Week 52 results from the FINCH 1 and 3 trials will be submitted for presentation at a future medical conference.
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