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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER