Gilead Sciences files RA candidate for Japanese approval

US biotech major Gilead Sciences (Nasdaq: GILD) yesterday announced that the New Drug Application (NDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults with rheumatoid arthritis (RA), has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for approval.

The NDA for filgotinib is supported by data from the Phase III FINCH clinical trial program in which once-daily treatment with filgotinib demonstrated the potential to improve clinical signs and symptoms, to achieve low disease activity and remission, and to inhibit structural damage for patients living with RA. Safety data across the FINCH clinical trial program was consistent with previously reported results.

Gilead gained rights to filgotinib from Galapagos (Euronext: GLPG) originally in 2015, but changed and expanding the agreement with the Belgium company in July this year, under a deal that could cost it more than $5 billion. The drug is currently under review with the European Medicines Agency and a US filing is expected this year. It has not yet been approved anywhere globally.