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Filgotinib is approved by the EMA for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults who have had an inadequate response to, or are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs). However, Filgotinib does not have FDA approval for the treatment of RA in the United States, as the FDA requested additional safety data - particularly regarding reproductive toxicity and sperm parameters - before granting marketing approval, which led to a delayed and ultimately not granted appro…