Gilead and Galapagos Reports the Validation of EMA’s MAA for Filgotinib to Treat Rheumatoid Arthritis

Gilead and Galapagos Reports the Validation of EMA’s MAA for Filgotinib to Treat Rheumatoid Arthritis

Shots:

  • The MAA is based on P-III FINCH studies assessing Filgotinib (qd) in patients with RA resulted in improvements in clinical signs & symptoms, low disease activity and remission, inhibition of structural damage for different sub-populations
  • The EMA will review Filgotinib filing under the centralized licensing procedure for all 28 member states of the EU as well as Norway, Iceland and Liechtenstein. Gilead plans to submit NDA to the US FDA in H2’19
  • 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: Washington Post