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Jyseleca (filgotinib) inhibits the action of Janus kinase enzymes, which are involved in the inflammation that causes the symptoms of rheumatoid arthritis and some other conditions.
Filgotinib, an orally administered, preferential JAK1 inhibitor, used in the induction and maintenance of remission in patients with Crohn’s disease (CD).
This latest regulatory submission is based on data from the randomized, double-blind, placebo-controlled Phase 2b/3 SELECTION study, This study showed the efficacy and tolerability of filgotinib 200 mg once daily, and no new safety risks were identified.
Of the 240 participants who were able to be evaluated after 13 weeks of treatment, sperm concentration fell by 50% or more in eight out of 120 in the filgotinib group and 10 out of 120 in the placebo group.