First once-daily RA drug approved

March 1, 2016

FDA has approved tofacitinib citrate extended-release (Xeljanz XR, Pfizer) tablets for the treatment of moderate to severe rheumatoid arthritis (RA).

FDA has approved tofacitinib citrate extended-release (Xeljanz XR, Pfizer) tablets for the treatment of moderate to severe rheumatoid arthritis (RA).

Xeljanz XR 11 mg tablets are now approved for the once-daily treatment of moderate to severe RA in patients who have had an inadequate response or intolerance to methotrexate. Xeljanz XR is the first and only once-daily oral RA treatment in its class. The medication may be used as a single agent or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).   

Related: Another win for biosimilar arthritis drugs

In addition to this new branded drug, FDA staff recently decided that Celltrion and Pfizer’s biosimilar (Remsima) to Johnson & Johnson’s RemicadE (infliximab) for rheumatoid arthritis was “highly similar” to the branded drug. Plus, FDA also recently accepted Amgen's application for ABP 501, a biosimilar to adalimumab, Humira (AbbVie) for RA.

Xeljanz XR is a prescription medication known as a Janus kinase (JAK) inhibitor. JAK enzymes are involved in signaling pathways that ultimately end in immune system activation. In patients with RA, Xeljanz XR is used to inhibit the JAK enzymes from activating the immune system’s attack on healthy tissue and thus improve the symptoms of RA.

The new drug approvals are notable, since RA affects approximately 23.7 million people worldwide and 1.6 million people in the United States.

Related: Sarilumab effective in broad range of RA patients: Study

 “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 Roy Fleischmann, MD, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and co-medical director of the Metroplex Clinical Research Center.

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

The most common adverse events associated with the use of Xeljanz in clinical trials included upper respiratory tract infections, headache, diarrhea, and nasopharyngitis. Xeljanz XR can also lower the ability of the immune system to fight infections, and some people can develop serious infections while on the medication. Xeljanz XR may also increase the risk of certain cancers by changing the way the immune system works. The risks and benefits of treatment should be considered before initiating treatment with Xeljanz XR.

At presstime, it was not known when Xeljanz XR would be available. 

Read more: Rheumatoid arthritis drug may benefit atopic dermatitis patients