Pfizer gets complete response letter from FDA for oral Xeljanz

US pharma giant Pfizer (NYSE: PFE) says it has received a complete response letter from the US Food and Drug Administration for its supplemental New Drug Application (sNDA) for Xeljanz (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 gave no further details of the agency’s request, but said it will work with the FDA to determine an appropriate path forward to address its comments, including providing additional safety analyses of Xeljanz for the proposed indication.

“Pfizer remains committed to Xeljanz based on the strength of the clinical data for the treatment of psoriasis,” said Kenneth Verburg, senior vice president and head of global medicines development, Global Innovative Pharma Business, adding: “It is our goal to work closely with the FDA to understand and address their comments about our filing for the use of Xeljanz in patients with chronic plaque psoriasis.”