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

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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

­ Ref: Gilead | Image : Gilead

Click here to­ read the full press release 

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