Gilead sub­mits an NDA for its big block­buster hope­ful

The head­lines for Gilead’s block­buster hope­ful fil­go­tinib have not al­ways been kind.

In ad­di­tion to the wider safe­ty con­cerns with JAK in­hibitors, Gilead’s ver­sion failed Phase II tri­als in Oc­to­ber in lu­pus and Sjö­gren’s. The two-part fail­ure of one of their biggest ac­qui­si­tions un­der­scored Gilead’s long-run­ning R&D strug­gles and set all eyes on the case they will now make to the FDA: that fil­go­tinib is safe and ef­fec­tive for rheuma­toid arthri­tis.

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