Shots:

• The filling of NDA is based on P-III FINCH clinical program assessing Filgotinib in 3-452 patients with moderate to severely active RA in people with prior inadequate response to MTX- those who were intolerant to one or more biologic treatments and those who were MTX treatment-naïve
• The study demonstrated meeting all 1EPs with durable efficacy and safety results in patients with RA and resulted in consistent safety and tolerability profile
• Filgotinib is an oral- selective JAK1 inhibitor targeted for the treatment of adults with moderate-to-severe RA and is the third regulatory submission in the past 5 mos. post-EMA- JMLW in H1’19

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 Ref: Gilead | Image: Gilead