Biopharmaceutical company Gilead Sciences Inc (NASDAQ:GILD) disclosed on Tuesday that it has filed its New Drug Application (NDA) for filgotinib for the treatment of adults with rheumatoid arthritis (RA) with the Japanese Ministry of Health, Labor and Welfare (MHLW).
According to the company, Filgotinib is an investigational, oral, selective JAK1 inhibitor for the treatment of adults with rheumatoid arthritis (RA)
The MHLW NDA for filgotinib is supported by data from the company's Phase 3 FINCH clinical trial programme, which investigated the efficacy and safety of 100 mg and 200 mg filgotinib once daily, in RA patient populations ranging from early stage to biologic-experienced patients. The primary endpoint was ACR20 at week 12.
According to the company, the once-daily treatment with filgotinib demonstrated the potential to improve clinical signs and symptoms, achieve low disease activity and remission as well as inhibit structural damage for patients living with RA. Safety data across the FINCH clinical trial programme was consistent with previous results. There are estimated to be up to one million people living with RA in Japan.
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