EMA lim­its use of JAK in­hibitors for at-risk groups in wake of safe­ty con­cerns

Fol­low­ing the US’ lead, the EMA is cut­ting back on the use of JAK in­hibitors for some pa­tients over a suite of safe­ty con­cerns.

The EMA’s safe­ty com­mit­tee is­sued new guid­ance on Fri­day, rec­om­mend­ing that a group of JAK in­hibitors used for chron­ic in­flam­ma­to­ry dis­or­ders are on­ly used in cer­tain at-risk pa­tients if no al­ter­na­tives are avail­able.

That in­cludes pa­tients 65 years and old­er, those at risk of ma­jor heart prob­lems, those who smoke or who have ex­ten­sive­ly in the past and those at risk of can­cer. Pa­tients at risk of blood clots in the lungs and deep veins (VTE) should take cau­tion, the com­mit­tee says, while rec­om­mend­ing low­er dos­es for some pa­tients at risk of VTE, can­cer or ma­jor heart prob­lems.

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Life Sciences Senior Associate

General Catalyst

San Francisco, CA, USA