On November 6, 2012 the Food and Drug Administration announced the approval of Xeljanz (tofacitinib) for the treatment of moderate and severe rheumatoid arthritis in adults who did not respond or were intolerant to methotrexate.
Badrul Chowdhury, M.D., Ph.D., stated, “Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate.” Chowdhury is the director of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products.
The FDA reports that rheumatoid arthritis is an autoimmune disease that causes the immune system to attack otherwise healthy joints and tissues around the joints. About 1.5 million Americans suffer from the disease.
The drug was approved before its projected fee goal date of November 21, 2012. Xeljanz will come in a pill form. The patient will take the pill twice a day in a hope to block molecules called “Janus kinases” which cause inflammation.
Side Effects of Xeljanz
During clinical trials, patients taking Xeljanz showed an increased risk of infections and especially opportunistic infections. These are infections that occur when the immune system is weakened. The drug can also can an increased chance of tuberculosis, lymphoma, and certain kinds of cancers. There is an increased chance of high cholesterol and a decrease liver enzymes in blood tests as well. Check the boxed warning with the drug for more information.
Because of the long term side effects of Xeljanz, the FDA has announced that it is scheduling a study in the future to look at the effects between different dosages and compare results to patients receiving other kinds of treatment.
The clinical testing involved a total of seven different clinical trials. The volunteers all had moderate or severe rheumatoid arthritis, and most saw improvements after taking Xeljanz compared to patients receiving a placebo.
Source: U.S. Food and Drug Administration
