Filgotinib testicular toxicity. Filgotinib was well tolerated, with no new safety events.
Filgotinib testicular toxicity. Filgotinib was well tolerated, with no new safety events. Aug 21, 2020 · One of the main reasons why the FDA rejected the NDA for filgotinib was concerns over testicular toxicity. Oct 9, 2024 · The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease (IBD). A specifically designed study will test the testicular safety of filgotinib in IBD patients (NCT03201445). The phase 2 MANTA and MANTA-RAy studies were developed in consultation with global regulatory authorities to investigate potential impacts of filgotinib, a Janus kinase 1 preferential inhibitor, on semen parameters in men with active inflammatory Aug 19, 2020 · As a potential fourth JAK inhibitor for moderate-to-severe RA and a serious contender in this arena, filgotinib has been plagued by lingering concerns regarding its testicular toxicity. Aug 19, 2020 · Analysts speculated that the testicular toxicity concerns may have factored into AbbVie’s decision to drop filgotinib in 2015 and focus on Rinvoq. . Importantly, animal studies have raised concerns about the potential testicular toxicity of filgotinib. There were no clinically relevant changes from baseline to week 13 in semen parameters or sex hormones, or patterns of reversibility between treatment groups. According to Gilead’s Sonia Choi, animal studies of filgotinib saw potentially harmful semen-related changes. mxh bmeyv jel pfxuh jzphys iphfy fyfh dopcs zczm vfua