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Gilead Reports Submission of NDA to MHLW for Filgotinib to Treat Rheumatoid Arthritis in Japan

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Gilead Reports Submission of NDA to MHLW for Filgotinib to Treat Rheumatoid Arthritis in Japan

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  • The NDA submission is based on P-III FINCH program- including FINCH 1- 2 & 3 study evaluating the safety & efficacy of Filgotinib (100/200mg- qd) in patients with RA ranging from early-stage to biologic-experienced patients
  • The P-III FINCH program demonstrated improvement in signs and symptoms- to achieve low disease activity and remission and inhibits structural damage in patients with RA. Safety data is consistent with the previous results
  • Filgotinib is an investigational- oral- selective JAK1 inhibitor being evaluated in P-II EQUATOR study for psoriatic arthritis- P-II TORTUGA study for ankylosing spondylitis- P-III DIVERSITY for Crohn’s disease and P-III SELECTION study for UC

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 Ref: Gilead | Image:Gilead


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