Gilead’s Jyseleca (filgotinib) Receives the MHLW’s Approval for Rheumatoid Arthritis in Japan

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• The approval is based on two clinical trials (P-III FINCH and P-II DARWIN) programs assessing Jyseleca in 3,500+ patients across a range of RA patient populations, including patients new to treatment and those who have demonstrated inadequate response to treatment with SOC including biologic DMARDs. Gilead and Eisai will jointly commercialize Jyseleca across Japan
• Results: improvement in clinical signs and symptoms, decreased disease activity and lessened the structural damage progression in their joints. Across the FINCH studies, Jyseleca demonstrated a consistent safety profile, and the frequency of AEs was comparable to control groups
• Jyseleca is a JAK1 inhibitor for the treatment of RA, in patients who have had an inadequate response to conventional therapies, including the prevention of structural joint damage

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