Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s in­ten­si­fy­ing scruti­ny on ac­cel­er­at­ed ap­provals isn’t just putting pres­sure on drug­mak­ers with mar­ket­ed prod­ucts. It is al­so sub­tly re­shap­ing the reg­u­la­to­ry dy­nam­ics.

Case in point: In­cyte an­nounced late Tues­day that it has made the “busi­ness de­ci­sion” to with­draw an NDA for parsaclis­ib, its oral PI3Kδ in­hibitor, af­ter de­cid­ing that run­ning the con­fir­ma­to­ry stud­ies the agency was ask­ing for to sup­port an ac­cel­er­at­ed ap­proval wouldn’t be worth it.

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