U.S. Food and Drug Administration approved Xeljanz (tofacitinib) to treat patients suffering from moderate to severe form of rheumatoid arthritis who are intolerant or unable to get any benefit from methotrexate.
RA is an autoimmune disorder in which body’s immune system attack on joint cells and causes inflammation and pain. It is estimated that 1.5 million people in US are suffering from RA. Xeljanz is a blocker of “Janus kinases,” molecules which play crucial role in the inflammation of joints.
It is available in tablet dosage form and can be prescribed twice daily.
“Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate,” said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
The safety and efficacy of Xeljanz was evaluated during the clinical trials conducted on patients suffering from RA. All participants received either drug or placebo randomly. Improved clinical response and physical functioning was observed in patients who took Xlejanz in comparison to those who received placebo.
Some common side effects associated with Xeljanz include, superinfections, cancer, tuberculosis, headache, diarrhea and lymphoma. It can also elevate the normal levels of liver enzymes and decrease blood count.
The marketing of Xeljanz is made New York-based Pfizer Inc.
Source: FDA News Release