Pfizer Receives Complete Response Letter for Xejanz
Pfizer has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for Xejanz (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The agency provided recommendations specific to the moderate to severe chronic plaque psoriasis sNDA. Pfizer will work with the FDA to determine an appropriate path forward to address their comments, including providing additional safety analyses for the proposed indication.
Xeljanz is a Janus kinase (JAK) inhibitor approved to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate (MTX) did not work well as a single agent or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs.