FDA Rejects Xeljanz Expanded Use for Plaque Psoriasis

Pfizer asked to provide additional safety analyses for proposed indication.

Pfizer asked to provide additional safety analyses for proposed indication.

The FDA has rejected Pfizer’s supplemental new drug application to expand the use of tofacitinib citrate (Xeljanz).

Pfizer sought to expand the use of Xeljanz, now used as a treatment for rheumatoid arthritis, to treat moderate to severe plaque psoriasis in adult patients.

The FDA’s complete response letter, which was sent to Pfizer, is given to a company when a product cannot be approved in its present form.

While the FDA did not approve the expanded indication, the administration did provide recommendations, including that Pfizer provide additional safety analyses 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, in a press release. “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.”

Adverse effects related to Xeljanz include upper respiratory tract infection, headache, diarrhea, and nasal congestion.