Pfizer Receives Complete Response Letter from FDA for Oral XELJANZ Supplemental New Drug Application for Moderate to Severe Chronic Plaque Psoriasis

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The FINANCIAL — Pfizer Inc. announced on October 14 it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) 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 will work with the Agency to determine an appropriate path forward to address their comments, including providing additional safety analyses of XELJANZ for the proposed indication, according to Pfizer.

“Pfizer remains committed to XELJANZ based on the strength of the clinical data for the treatment of psoriasis,” said Kenneth Verburg, PhD, senior vice president and head of global medicines development, Global Innovative Pharma Business. “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.”

Psoriasis affects 7.4 million people in the United States.1 The most common form is plaque psoriasis, which affects about 80 percent of people who have the condition.2a Of those, as many as 20 percent have moderate to severe chronic plaque psoriasis.

 

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