Mar 28, 2022 22:38 JST

Source: Eisai

Eisai: Announcement About an Approval for Additional Indication of Jyseleca, JAK inhibitor
For the treatment of moderate to severe ulcerative colitis with inadequate response to conventional therapies

Approval of additional indication based on Phase IIb/III SELECTION data for patients with active moderate-to-severe ulcerative colitis

TOKYO, Mar 28, 2022 - (JCN Newswire) - 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 is a chronic inflammatory disease with sores and ulcers forms on the lining of the large intestine, and it accompanies by symptoms such as blood in stool, diarrhea and abdominal pain during the active stage. Despite advances in the treatment of ulcerative colitis, there is no curative treatment, and it is important to promptly induce remission and maintain remission to prevent relapse of inflammation. Because of persistent inflammation, there remains unmet medical needs as many patients still suffer from symptoms that affect their daily lives. With the approval for the additional indication, which showed the efficacy and safety in the induction and maintenance of remission, I am pleased that it provides a new treatment option for patients with unmet medical needs."

Dr. Mamoru Watanabe, Vice president of Tokyo Medical and Dental University, commented "Jyseleca is a new JAK inhibitor and in clinical studies, the efficacy and safety profile of Jyseleca for induction and maintenance of remission were demonstrated in patients with moderately to severely active ulcerative colitis who are biologic- naive and biologic-experienced. With the approval for the additional indication, I expect to see further progress in the treatment of ulcerative colitis."

Gilead and Eisai co-market Jyseleca for rheumatoid arthritis indication in Japan. Gilead and EA Pharma, which has been commissioned by Eisai, will co-promote the additional indication of ulcerative colitis. Gilead, Eisai and EA Pharma will expand the therapeutic options for ulcerative colitis and strive to further contribute to improving the QOL of patients and their families through Jyseleca.

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Source: Eisai
Sectors: BioTech

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