(By Balachander) Pfizer Inc. (NYSE: PFE) said the U.S. Food and Drug Administration (FDA) approved its Xeljanz to treat rheumatoid arthritis (RA).
The U.S. health regulators approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.
According to the Centers for Disease Control and Prevention, RA affects an estimated 1.5 million Americans.
Xeljanz, a pill taken twice daily, works by blocking molecules called "Janus kinases," which are important in the joint inflammation of RA.
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"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, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.
The FDA approved Xeljanz ahead of the product's prescription drug user fee goal date of Nov. 21, 2012.
In seven clinical trials in adult patients with moderately to severely active RA, patients treated with Xeljanz experienced improvement in clinical response and physical functioning compared to patients treated with placebo, the FDA said.
The most common adverse reactions in clinical trials were upper respiratory tract infections, headache, diarrhea, and inflammation of the nasal passage and the upper part of the pharynx.
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"We are proud of the comprehensive data that support the use of XELJANZ, and we are excited to make it available to patients in the U.S. as a powerful oral option that can be taken as a second-line treatment with or without methotrexate," said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer.
Shares of the New York-based company traded 0.57 percent lower at $24.35 on Wednesday.