Complete Response Letter Issued for Xeljanz on New Indication

Pfizer announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate) for the treatment of adults with moderate to severe chronic plaque psoriasis.

Pfizer will work with the FDA to address their recommendations specific to the moderate to severe chronic plaque psoriasis sNDA, including providing additional safety analyses of Xeljanz for the proposed indication.

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Xeljanz (tofacitinib citrate) is a Janus kinase (JAK) Inhibitor currently approved for the treatment of moderate to severe rheumatoid arthritis (RA) as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).

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