Pfizer's Arthritis Drug Gets FDA Nod For Label Expansion
Zacks Investment Research | Dec 15, 2017 02:37AM ET
Pfizer Inc. (NYSE:PFE) announced that the FDA has approved a label expansion for its janus kinase (JAK) inhibitor, Xeljanz (tofacitinib), for two doses — 5 mg twice daily and 11 mg once-daily extended-release (XR) formulation.
With this latest approval, Xeljanz can now be administered for treating adult patients with active psoriatic arthritis (PsA), who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and tumor necrosis factor inhibitors, respectively.
Notably, Xeljanz (5 mg twice daily) is approved in the United States as a second-line treatment option for patients with moderate-to-severely active rheumatoid arthritis (“RA”), who have had an inadequate response to or cannot tolerate methotrexate (MTX). The drug was approved in Europe and China in March for RA. Significantly, this is the first and only JAK inhibitor approved in the United States for both moderate to severe RA and an active PsA.
Shares of Pfizer have gained 12.3% so far this year, underperforming the Zacks Investment Research
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