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news.The US Food and Drug Administration (FDA) has accepted for review Pfizer's supplemental New Drug Application (sNDA) seeking approval for the use of Xeljanz (tofacitinib citrate) 5mg and 10mg tablets to treat adult patients with moderate-to-severe plaque psoriasis.
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For the sNDA, the anticipated Prescription Drug User Fee Act (PDUFA) action date will be in October 2015.
The submission of sNDA was based on data from a global, multi-study Phase III Oral treatment Psoriasis Trials (OPT) Program that included five studies designed to evaluate oral XELJANZ 5mg and 10mg twice daily in patients with moderate to severe chronic plaque psoriasis.
Xeljanz is a small molecule Janus kinase (JAK) inhibitor that is currently approved in 37 countries for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA).
In the US, Xeljanz 5mg tablets are approved to treat adults with moderate to severe RA who have had an inadequate response or intolerance to methotrexate (MTX).
Pfizer Global Innovative Pharmaceutical business senior vice-president and head of Global Medicines Development Steve Romano said: "This regulatory milestone demonstrates our commitment to the research of chronic inflammatory diseases with the goal of developing therapies, such as Xeljanz, that can help address unmet medical needs for patients."
The company said that Xeljanz can lower the ability of the immune system to fight infections and some people taking the drug have serious infections such as tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body.
Image: In the US, Xeljanz 5mg tablets are approved to treat RA patients. Photo: courtesy of Pfizer Inc.