FDA push­es eczema de­ci­sion for Eli Lil­ly's Olu­mi­ant, Pfiz­er's abroc­i­tinib back 3 months — rais­ing more ques­tions for the JAK class

The FDA re­view ex­ten­sions for JAK in­hibitors are stack­ing up.

Af­ter Eli Lil­ly and In­cyte dis­closed late Tues­day that their sup­ple­men­tal NDA for Olu­mi­ant in mod­er­ate to se­vere atopic der­mati­tis was hit with a 3-month de­lay, Pfiz­er re­vealed ear­ly Wednes­day that its ex­per­i­men­tal abroc­i­tinib is meet­ing the same fate. With Olu­mi­ant, the agency need­ed time to “re­view ad­di­tion­al da­ta analy­ses sub­mit­ted by Lil­ly in re­sponse to re­cent in­for­ma­tion re­quests from the FDA,” ac­cord­ing to a state­ment. Pfiz­er didn’t spec­i­fy a rea­son in its re­lease.

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