FDA Advisory Arm Backs XELJANZ for PsA

Friday, August 04, 2017 | FDA Approval/Clearance , Psoriasis , Pfizer

The United States Food and Drug Administration’s (FDA) Arthritis Advisory Committee recommends the approval of Pfizer's XELJANZ® (tofacitinib) for the treatment of adults with active psoriatic arthritis (PsA).

The Arthritis Advisory Committee voted 10 to 1 in favor of approving XELJANZ®, a Janus kinase (JAK) inhibitor.The FDA is not obligated to follow the advice of their advisory panel, but they usually do. The FDA decision is anticipated by December 2017.  

Pfizer submitted supplemental new drug applications for XELJANZ® 5 mg twice daily (BID) and XELJANZ® XR extended release 11 mg once daily (QD) for this pending indication.




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