FDA Approves Once-Daily Rheumatoid Arthritis Oral Drug, Xeljanz XR, by Pfizer

FDA Approves Once-Daily Rheumatoid Arthritis Oral Drug, Xeljanz XR, by Pfizer

Pfizer, Inc., recently announced that the U.S. Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib citrate) extended-release 11 mg tablets as a once-daily treatment of patients with moderate to severe rheumatoid arthritis (RA) who have not responded adequately to, or are intolerant of, methotrexate (MTX).

Tofacitinib (Xeljanz) in 2012 became the first selective oral Janus kinase (JAK) inhibitor to be approved by the FDA. JAKs are enzymes, or proteins, that regulate chemical signaling pathways that control biologic processes such as blood formation and the immune response that causes the pain, tenderness, and swelling of inflammation. Tofacitinib interrupts signaling of several cytokines involved in this immune response.

Xeljanz XR is the first and only once-daily oral JAK inhibitor available for patients with moderate to severe RA. Both Xeljanz and Xeljanz XR can be taken with or without methotrexate.

Globally, Xeljanz is approved in over 45 countries as a first-line treatment option for patients with moderate to severe RA after failure of one or more disease-modifying antirheumatic drugs (DMARDs).

“Pfizer continues to be an innovator in inflammation and immunology. 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,” Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business, said in a recent press release.

“The availability of XELJANZ XR provides physicians with a new treatment option for people with RA who may prefer an oral once-daily treatment,” said Dr. Roy Fleischmann, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and co-medical director, Metroplex Clinical Research Center.

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease of unknown cause. An external stimulus (like cigarette smoking, infection, or trauma) that triggers an autoimmune reaction, leading to synovial hypertrophy and chronic joint inflammation along with the potential for extra-articular manifestations, is theorized to occur in genetically susceptible individuals. RA is a common chronic disease that affects about 1 percent of the world’s population. Its prevalence in the U.S. is currently estimated at about 1.29 million people, or 0.6 percent of the population.

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