US regulators have turned down Pfizer’s request to sell its rheumatoid arthritis drug Xeljanz as a treatment for chronic plaque psoriasis.
The US Food and Drug Administration has issued Pfizer with a complete response letter outlining its objections to approving Xeljanz (tofacitinib citrate) at this time.
The details haven’t been disclosed in full, but the drugs giant said it would now work with the Agency to determine an appropriate path forward to address its comments, “including providing additional safety analyses of Xeljanz for the proposed indication”.
Xeljanz is a JAK inhibitor green-lighted in the US back in 2012 a second-line therapy for RA after failure of one or more disease-modifying antirheumatic drugs (DMARDs). The FDA is also currently review a once-daily formulation of the drug for RA patients.