FDA approves Pfizer’s Xeljanz XR to treat rheumatoid arthritis

Pfizer claims that the drug is the first once-daily oral RA treatment in its class of Janus kinase (JAK) inhibitors.

Xeljanz is indicated to treat adults with moderately to severely active RA in which methotrexate did not work well.

Xeljanz/Xeljanz XR may also be used as a single agent or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs).

Pfizer global innovative pharmaceuticals business category development lead of inflammation & immunology 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-centered therapies."

Xeljanz is approved in over 45 countries across the world to treat moderate to severe RA as a second-line therapy after failure of one or more DMARDs.

Pfizer said it is committed to advancing the science of JAK inhibition and improving understanding of Xeljanz via a clinical development program.

The company studied efficacy and safety profile of Xeljanz in about 6,200 patients with moderate to severe RA, resulting in over 19,400 patient-years of drug exposure in the worldwide clinical development program.

RA is a chronic, inflammatory autoimmune disease that leads to several symptoms such as pain and swelling in the joints, especially those in the hands, feet and knees.

The disease affects about 23.7 million people globally and 1.6 million people in the US.

Image: Pfizer world headquarters. Photo: courtesy of Jim.henderson.