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Carol Eustice

Committee to European Medicines Agency Rejects Xeljanz for Rheumatoid Arthritis

By April 27, 2013

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You may recall that the U.S. FDA approved Xeljanz (tofacitinib) in November 2012 for the treatment of adults with moderately- to severely-active rheumatoid arthritis who had an inadequate response or an intolerance to methotrexate. Xeljanz was the first oral, non-biologic, disease-modifying anti-rheumatic drug approved by the FDA in over 10 years. Xeljanz is also the first drug in a new class of drugs known as JAK (Janus kinase) inhibitors. Its approval was highly anticipated since Xeljanz is viewed as a competitor to injectable biologic drugs, such as Humira, Enbrel, and Remicade.

It was announced on April 25, 2013 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency did not recommend approval of Xeljanz. The committee said that data from 5 studies on the safety and effctiveness of Xeljanz, when considered together, showed that the drug did improve the signs and symptoms of rheumatoid arthritis, as well as physical function but there was not a consistent reduction in disease activity and structural damage to joints, especially at the lower (5 mg.) dose. The CHMP also cited safety concerns including an increased risk of serious infections, certain cancers, gastrointestinal perforations, liver damage, and increased lipid levels in the blood. Pfizer, the maker of Xeljanz, can request a reconsideration.

The FDA required a black box warning on Xeljanz as a condition of approval last year. It also has required Pfizer to conduct a postmarketing study to assess the drug's risk of heart disease, cancer, and serious infection.

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