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Tofacitinib is approved by both the FDA and the EMA for the treatment of rheumatoid arthritis (RA). The FDA granted approval for Tofacitinib (brand name Xeljanz) for adult patients with moderate to severe active RA who have had an inadequate response to or are intolerant of Methotrexate.
The EMA has also approved Tofacitinib for the same indication, allowing its use either as monotherapy or in combination with Methotrexate or other DMARDs. Following approval, both agencies issued safety warnings…