Watch out Ab­b­Vie: Gilead is fast on your heels at the FDA with ri­val JAK in­hibitor fil­go­tinib

Mov­ing fast with what it be­lieves is a block­buster fa­vorite in a crowd­ed mar­ket, Gilead has con­fi­dent­ly plot­ted an NDA fil­ing for fil­go­tinib by the end of the year, set­ting up a po­ten­tial 2020 launch in rheuma­toid arthri­tis.

Smooth progress here would min­i­mize Ab­b­Vie’s lead, as its ri­val JAK in­hibitor upadac­i­tinib is al­ready un­der pri­or­i­ty re­view with a PDU­FA date set for Q3. For an­a­lysts, it’s al­so a tes­ta­ment to new CEO Dan O’Day’s abil­i­ty to ex­e­cute on key pipeline ad­vances, hav­ing hint­ed at the quick fil­ing in an in­vestor call — though ques­tions about a cru­cial safe­ty study re­main unan­swered.

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