EMA ini­ti­ates safe­ty re­view on JAK in­hibitors; Gala­pa­gos woes con­tin­ue as it ter­mi­nates lat­est study 

Fol­low­ing the FDA’s is­suance of a safe­ty warn­ing re­gard­ing JAK in­hibitors, the safe­ty com­mit­tee of the Eu­ro­pean Med­i­cines Agency on Fri­day ini­ti­at­ed a re­view of these treat­ments, which are used to treat sev­er­al chron­ic in­flam­ma­to­ry dis­or­ders like rheuma­toid arthri­tis and atopic der­mati­tis.

The EMA’s PRAC said its re­view was prompt­ed by the fi­nal re­sults from a clin­i­cal tri­al (study A3921133) of Pfiz­er’s JAK in­hibitor Xel­janz (to­fac­i­tinib), which showed pa­tients tak­ing Xel­janz for rheuma­toid arthri­tis and who were at risk of heart dis­ease were more like­ly to ex­pe­ri­ence a ma­jor car­dio­vas­cu­lar prob­lem and had a high­er risk of de­vel­op­ing can­cer than those treat­ed with TNF-al­pha in­hibitors.

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