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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER