FDA approves Xeljanz (Pfizer) to treat Rheumatoid Arthritis

The FDA has approved Xeljanz (tofacitinib) , from Pfizer,on 6 November 2012, to treat adults with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate. The safety and effectiveness of Xeljanz were evaluated in seven clinical trials in adult patients with moderately to severely active RA. In all of the trials, patients treated with Xeljanz experienced improvement in clinical response and physical functioning compared to patients treated with placebo.

The use of Xeljanz was associated with an increased risk of serious infections, including opportunistic infections (infections that occur primarily when the immune system is suppressed), tuberculosis, cancers and lymphoma. Accordingly, Xeljanz carries a Boxed Warning regarding these safety risks. Xeljanz treatment is also associated with increases in cholesterol and liver enzyme tests and decreases in blood counts.The FDA approved Xeljanz with a Risk Evaluation and Mitigation Strategy.