TOKYO, Mar 28, 2022 - (JCN Newswire via SEAPRWire.com) - Gilead Sciences K.K., Eisai Co., Ltd. and EA Pharma Co., Ltd. announced that Gilead acquired an approval of additional indication of Jyseleca (Generic name: Filgotinib, "Jyseleca"), Janus Kinase (JAK) inhibitor, for the treatment of patients with active moderate-to-severe ulcerative colitis in Japan. In September 2020, Jyseleca was approved for the treatment of patients with rheumatoid arthritis (including prevention of structural joint damage) who had an inadequate response to conventional therapies in Japan. The approval of the additional indication is based on the data from Phase IIb/III SELECTION trial evaluating the efficacy and safety of Jyseleca in the induction and maintenance treatment of biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis. The trial comprises of two induction studies and one maintenance study. The trial showed the efficacy and safety profile of Jyseleca, and no new safety risks were identified. Dr. Norifumi Hibi, Director of the Center for Advanced Treatment of Inflammatory Bowel Disease at Kitasato Institute Hospital, commented "Ulcerative colitis ...