Xeljanz Receives New Pediatric Indication

September 28, 2020 – The U.S. FDA has approved a new indication for Xeljanz® (tofacitinib), manufactured by Pfizer, to treat patients who are at least two years old and have active polyarticular course juvenile idiopathic arthritis (pcJIA). The approval was granted for both the existing tablet dosage form and a new oral solution dosage form of the drug.

A subset of juvenile idiopathic arthritis, pcJIA is a potentially debilitating disease that affects multiple joints in the body. It can affect both the small joints (such as in the hands and feet) and large joints (such as the knees and hips) of the body. Patients who have pcJIA experience chronic inflammation and pain that can prevent them from pursuing typical daily activities.

In a clinical study, the incidence of disease flares was significantly lower in patients treated with Xeljanz compared to patients who received a placebo. The safety profile for Xeljanz in pediatric patients was similar to that seen in adults.

Although the tablet dosage form is currently available, the new oral solution form as not yet launched. Recommended dosing for either dosage form under the new indication is based on weight and other individual patient factors, including lab results and other medications the patient may be taking. A black box warning cautions there is a risk of serious infection, cancer, blood clots (thrombosis), and death associated with the use of Xeljanz.

First FDA approved in 2012, Xeljanz is also indicated to treat adults who have rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.