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Pfizer's NDA for once-daily XELJANZ modified release tablets to be reviewed by the US FDA for rheumatoid arthritis
3 July 2015 - Healthcare company Pfizer (NYSE:PFE) stated on Thursday that the new drug application (NDA) for XELJANZ (tofacitinib citrate) 11 mg once daily modified release tablets has been accepted for review by the US Food and Drug Administration (FDA) for the treatment of moderate to severe rheumatoid arthritis (RA).The company added that the US FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in February 2016 for the NDA for XELJANZ (tofacitinib citrate) 11 mg once daily modified release tablets for treating moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX).According to the company, the NDA for XELJANZ 11 mg once daily modified release is based on data from a clinical pharmacology programme designed to demonstrate equivalence in key pharmacokinetic parameters to XELJANZ 5 mg twice daily. It is approved in 40 countries for moderate to severe rheumatoid arthritis (RA).In conjunction, the company has studied the benefit:risk profile of XELJANZ in RA in approximately 6,200 patients in the global clinical development programme for XELJANZ in moderate to severe RA. XELJANZ is a prescription medicine called a Janus kinase (JAK) inhibitor. The recommended dose is 5 mg twice-daily (BID) and may be used as a single agent or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs).Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease that causes a range of symptoms, including stiffness and swelling in the joints, particularly those in the hands, feet and knees.
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