Up­dat­ed: JAK woes con­tin­ue as Eli Lil­ly warns of pos­si­ble Olu­mi­ant CRL for atopic der­mati­tis and re­ports PhI­II fail in lu­pus

Eli Lil­ly and In­cyte have plans to turn their block­buster Olu­mi­ant drug in­to a megablock­buster. But those plans ran in­to a ma­jor road­block Fri­day morn­ing.

The FDA does not agree with the com­pa­nies on which atopic der­mati­tis pa­tients should re­ceive the drug, pos­si­bly lead­ing to a CRL in the in­di­ca­tion, the pair an­nounced. Lil­ly and In­cyte had sub­mit­ted an sN­DA in atopic der­mati­tis back in 2020, and it has been de­layed mul­ti­ple times as reg­u­la­tors con­tin­ue to ex­press safe­ty con­cerns in the en­tire JAK in­hibitor class.

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