New Arthritis Drug Xeljanz Gets FDA Approval

By Daniel J. DeNoon
WebMD Health News

Reviewed by Louise Chang, MD

Nov. 6, 2012 -- The FDA has approved Pfizer's Xeljanz (tofacitinib), a first-of-its-kind treatment for rheumatoid arthritis.

Xeljanz is approved for use by patients not helped by methotrexate, the usual first treatment for RA. It's a pill taken twice a day.

Xeljanz is a type of drug called a Janus kinase or JAK inhibitor. Blocking JAK mutes the inflammation responses responsible for RA.

"Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate," says Badrul Chowdhury, MD, PhD, the FDA's head of pulmonary, allergy, and rheumatology products.

Some 70% of RA patients eventually stop responding to methotrexate. Some 1.5 million Americans suffer from RA.

In clinical trials, patients taking Xeljanz had better physical functioning than patients taking an inactive placebo pill. But because it inhibits immune responses, Xeljanz adds to a person's risk of serious infections, cancers, and lymphoma. The drug will carry a "black box" warning about these risks.

People taking Xeljanz also had higher cholesterol levels, lower blood counts, and increased liver enzyme levels. Prescriptions will come with a medication guide carrying important safety information and a plan for informing health care providers about the drug's serious risks.

More common side effects associated with Xeljanz are upper respiratory tract infections, headache, diarrhea, and inflammation of the nasal passage and the upper part of the throat.

Because Xeljanz dampens out-of-control immune responses, it's being explored as a treatment for other autoimmune diseases such as psoriasis.

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SOURCES: News release, FDA. FDA Advisory Committee Meeting, May 9, 2012, briefing documents.

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