PhI­II im­plo­sion forces Gala­pa­gos to scrap a fil­ing plan for fil­go­tinib

Gala­pa­gos is block­ing off one more de­vel­op­ment path for fil­go­tinib, its JAK in­hibitor with a check­ered his­to­ry, in the wake of a neg­a­tive Phase III read­out.

The drug — which is ap­proved in Eu­rope and Japan for oth­er con­di­tions as Jy­s­e­le­ca — failed one of two co-pri­ma­ry end­points in a tri­al for Crohn’s dis­ease, miss­ing the bar on clin­i­cal re­mis­sion and en­do­scop­ic re­sponse as an in­duc­tion treat­ment. While it did hit the oth­er co-pri­ma­ry end­point as a main­te­nance ther­a­py, Gala­pa­gos said it will not file for mar­ket­ing au­tho­riza­tion in Eu­rope based on the topline da­ta.

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