JAK in­hibitor PDU­FA dates ex­tend­ed again as safe­ty re­view con­tin­ues; Stem­son se­cures $15M to cure hair loss

Two more sup­ple­men­tal new drug ap­pli­ca­tions have been de­layed again — this time from Ab­b­Vie, and the part­ners Eli Lil­ly and In­cyte — as the FDA con­tin­ues its on­go­ing safe­ty as­sess­ment of the class of drugs known as JAK in­hibitors.

The agency is con­tin­u­ing to eval­u­ate Pfiz­er’s failed post-mar­ket­ing tri­al, known as ORAL Sur­veil­lance, which showed those who re­ceived ei­ther a low or high dose of its JAK in­hibitor Xel­janz ex­pe­ri­enced more ma­jor car­dio­vas­cu­lar events — such as stroke and heart at­tack — than those on Hu­mi­ra or En­brel. They al­so had high­er rates of can­cer, with Pfiz­er fail­ing to hit non-in­fe­ri­or­i­ty on both pri­ma­ry end­points.

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