Gilead Sciences announced Tuesday that it plans to seek US approval of the oral JAK1 inhibitor filgotinib this year following recent discussions with the FDA. The company, which is developing the drug in partnership with Galapagos, noted that after talks with the agency, a path forward has been established to submit a filing as a treatment for rheumatoid arthritis.
According to Gilead, the drugmaker discussed the Phase III FINCH studies with the FDA, as well as the ongoing Phase II MANTA safety trial assessing semen parameters with filgotinib treatment in men with moderately-to-severely active ulcerative colitis or Crohn's disease. Gilead reported in March that the FINCH 1 and 3 studies in adults with moderately-to-severely active rheumatoid arthritis met their primary endpoints, while the FINCH 2 trial had earlier hit its main goal (for related analysis, see ViewPoints: Gilead, Galapagos get on the FDA's good side with filgotinib.
Gilead and Galapagos are jointly developing filgotinib under a 2015 agreement potentially worth more than $2 billion. Galapagos had previously regained full rights to the therapy after AbbVie declined an option to in-license the drug.
For further analysis, read ViewPoints: Gilead's filgotinib breaks the JAK inhibitor safety trend, and KOL Views Results: Leading RA expert questions filgotinib's efficacy and not yet sold on safety as a differentiator.
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