In­cyte pulls away 'dam­aged good­s' baric­i­tinib to fo­cus on in­ter­nal pipeline

Jakafi-mak­er In­cyte has ef­fec­tive­ly made Olu­mi­ant (baric­i­tinib) — the tar­nished JAK in­hibitor dogged by safe­ty con­cerns that bare­ly crossed the FDA fin­ish line with a small­er dose — Eli Lil­ly’s prob­lem.

Last June, the FDA ap­proved on­ly the small 2 mg dose of the drug — which In­cyte part­nered with Lil­ly on — with a black box warn­ing high­light­ing the ther­a­py’s side ef­fects, in­clud­ing a star­tling throm­boem­bolism sig­nal, quash­ing Lil­ly’s block­buster dreams. The agency had ini­tial­ly re­ject­ed the drug, de­mand­ing a new study, but un­der the lead­er­ship of now for­mer FDA com­mis­sion­er Scott Got­tlieb, the FDA had an un­ex­plained change of heart, and al­lowed the mar­ket­ing ap­pli­ca­tion to pro­ceed.

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