FDA approves tofacitinib for rheumatoid arthritis therapy

The FDA today approved tofacitinib for treating adults with moderate to severe rheumatoid arthritis who experienced inadequate response to or cannot tolerate methotrexate, according to a press release.

Dosage for Xeljanz (tofacitinib, Pfizer), which blocks Janus kinases, will be twice daily, according to an FDA press release. The FDA had planned to complete review of the oral drug’s application by Nov. 21.

In seven clinical trials, the FDA said, adult patients with moderate to severe rheumatoid arthritis (RA) treated with tofacitinib experienced improved clinical response and physical functioning compared with placebo-treated patients. Serious infection risk associated with tofacitinib included opportunistic infections, tuberculosis, cancers and lymphoma. Xeljanz, which is associated with increases in cholesterol and liver enzyme test and decreases in blood count, will include a boxed warning explaining the risks.

The FDA’s approval also included a Risk Evaluation and Mitigation Strategy, consisting of a medication guide to advise patients about safety information and a communications plan for health care providers regarding serious risks associated with tofacitinib.

The most common adverse reactions during the trials were upper respiratory tract infections, headache, diarrhea, and nasal passage and upper pharynx inflammation, the release said.

The FDA is requiring a postmarketing study to evaluate tofacitinib’s long-term effects on heart disease, cancer and serious infections.

“Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA,” Badrul Chowdhury, MD, PhD, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said.