This article is more than 5 years old. Information may no longer be current.
FDA adds new warnings to Xeljanz label
Click Here to Manage Email Alerts
The FDA announced it has updated the safety labeling information regarding infection risks for the rheumatoid arthritis treatment, Xeljanz, issued by the FDA Center for Drug Evaluation and Research.
Two additional warnings were added to the label. One refers to an increased risk of viral reactivation of herpes zoster that may be present in patients treated with Xeljanz (tofacitinib, Pfizer), particularly in Japan, and the second update states that “caution should be used” when prescribing tofacitinib to patients with diabetes due to an overall preexisting increased infection risk in this patient population.
Currently, tofacitinib is approved for the treatment of rheumatoid arthritis, but it is also being studied by Pfizer and separately by several universities for the treatment of plaque psoriasis, psoriatic arthritis and by several universities for alopecia areata. Pfizer recently announced it submitted a new drug application to the FDA for a new, once-daily dosing formulation of the Janus kinase inhibitor.
In the press release, Rory O’Connor, MD, senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, at Pfizer said, “If approved, it would bring us one step closer to offering the first and only once-daily oral Janus kinase inhibitor treatment for those living with moderate-to-severe RA who have had an inadequate response or intolerance to methotrexate.”
After publication, a representative from Pfizer responded to the FDA's action.
“The decision to update the label for Xeljanz follows the FDA’s review of data submitted by Pfizer from several studies assessing the safety of Xeljanz in these patient populations,” the representative wrote to www.Healio.com/Rheumatology. “All of these data have been previously disclosed. Pfizer believes the data from the global clinical development program to date show that Xeljanz has a favorable benefit:risk profile for use in patients with moderate to severe RA. We remain committed to further studying the safety and efficacy of Xeljanz in ongoing, planned observational and interventional studies.”
Reference: www.fda.gov.