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

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