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February 24, 2016

Pfizer receives FDA approval for Xeljanz XR to treat rheumatoid arthritis

Pfizer has received the US Food and Drug Administration (FDA) approval for its Xeljanz XR (tofacitinib citrate) extended-release tablets for the treatment of rheumatoid arthritis (RA).

Rheumatoide

Pfizer has received the US Food and Drug Administration (FDA) approval for its Xeljanz XR (tofacitinib citrate) extended-release tablets for the treatment of rheumatoid arthritis (RA).

Xeljanz XR is the first and only once-daily oral RA treatment in its Janus kinase (JAK) class inhibitors.

The 11mg Xeljanz XR tablets can now be used once in a day to treat moderate to severe RA in patients who have had an inadequate response or intolerance to methotrexate, the company said.

This oral JAK inhibitor does not require injections or infusions and can be taken with or without methotrexate.

Pfizer global innovative pharmaceuticals business inflammation and immunology category development lead Michael Corbo said: "The introduction of the first and only once-daily oral JAK inhibitor for RA, Xeljanz XR, builds upon Pfizer’s tradition of developing patient-centred therapies."

"The introduction of the first and only once-daily oral JAK inhibitor for RA, Xeljanz XR, builds upon Pfizer’s tradition of developing patient-centred therapies."

Xeljanz XR is approved in more than 45 countries for the treatment of moderate to severe RA as a second-line therapy, after failure of one or more disease-modifying anti-rheumatic drugs (DMARDs).

The use of Xeljanz XR in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine is not recommended.

University of Texas Southwestern Medical Centre department of internal medicine clinical professor Dr Roy Fleischmann said: "The availability of Xeljanz XR provides physicians with a new treatment option for people with RA who may prefer an oral once-daily treatment."

The efficacy and safety of Xeljanz has been studied in nearly 6,200 patients with moderate to severe RA, amounting to more than 19,400 patient-years of drug exposure in the global clinical development programme.


Image: X-ray of the hand in rheumatoid arthritis. Photo: courtesy of Bernd Brägelmann.

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