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news.Drugmaker Pfizer has received recommendations from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for Xeljanz (tofacitinib citrate) to treat adult patients with moderate to severe chronic plaque psoriasis.
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FDA has provided recommendations specific to the moderate to severe chronic plaque psoriasis sNDA.
Pfizer said that it will work with FDA to determine an appropriate path forward to address their remarks, including providing additional safety analyses of Xeljanz for the proposed indication.
Pfizer global innovative pharma business’ global medicines development head and senior vice president Dr Kenneth Verburg said: "Pfizer remains committed to Xejanz based on the strength of the clinical data for the treatment of psoriasis.
"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."
Xeljanz is a prescription medicine known as Janus kinase (JAK) inhibitor. It is claimed to be the only JAK inhibitor approved in around 40 countries to treat moderate to severe rheumatoid arthritis (RA) as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).
In July, the FDA accepted to review Pfizer’s NDA for Xeljanz 11mg once daily modified release tablets to treat moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX).
The NDA of Xeljanz 11mg is based on data from a clinical pharmacology program designed to show equivalence in key pharmacokinetic parameters to Xeljanz 5mg twice daily.