Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA ap­proved Pfiz­er’s JAK in­hibitor Xel­janz for rheuma­toid arthri­tis in 2012, they slapped on a black box warn­ing for a laun­dry list of ad­verse events and re­quired the New York drug­mak­er to run a long-term safe­ty study.

That study has since be­come a con­sis­tent headache for Pfiz­er and their block­buster mol­e­cule. Last year, Pfiz­er dropped the en­tire high dose co­hort af­ter an in­de­pen­dent mon­i­tor­ing board found more pa­tients died in that group than in the low dose arm or a con­trol arm of pa­tients who re­ceived one of two TNF in­hibitors, En­brel or Hu­mi­ra.

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