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

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

Shots:

  • 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

Click here to­ read full press release/ article | Ref: Gilead | Image: Pharmaceutical Technology