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Eisai: Announcement About an Approval for Additional Indication of Jyseleca, JAK inhibitor

ruth
3 minutes

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 ...

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AbbVie and Eisai Announce an approval for additional indication of HUMIRA

ruth
3 minutes

TOKYO, Nov 27, 2020 - (JCN Newswire) - AbbVie GK and Eisai Co., Ltd. today announced an approval of additional indication of HUMIRA (generic name: adalimumab [recombinant], hereafter "HUMIRA"), a fully human anti-TNFalpha monoclonal antibody, for the treatment of pyoderma gangrenosum (hereafter "PG"). HUMIRA was granted orphan drug designation for the treatment of PG in 2019. This indication counts for HUMIRA's 12th indication in Japan and makes HUMIRA the world's first drug indicated for the treatment of PG.This approval of the additional indication is based on the data from the Japanese phase III clinical trial(1) conducted in Japanese patients. This study was conducted to evaluate the efficacy and safety of HUMIRA targeting the patients with active ulcers in Japan who were diagnosed with PG but were not sufficiently effective with local treatment, or who were judged to be unsuitable for local treatment. The proportion of patients achieving at 100 (targeted PG ulcer healed) of the target pyoderma gangrenosum ulcer area reduction (PG Area Reduction: PGAR) at Week 26 of administration, which is the primary endpoint of this trial, was 54.5% (12 of 22 patients)1. The most common adve...