ObsEva Submits NDA Of Linzagolix To FDA For Treatment Of Uterine Fibroids

ObsEva向FDA提交Linzagolix的NDA用于治疗子宫肌瘤

2021-09-15 14:30:10 RTTNews

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ObsEva SA said Wednesday that it has submitted a New Drug Application to the U.S. Food and Drug Administration for linzagolix for the treatment of uterine fibroids. Linzagolix is an oral GnRH receptor antagonist with potential best-in-class efficacy, favorable tolerability profile, and unique and flexible dosing options. Further, if approved, linzagolix will be the only GnRH antagonist in uterine fibroids with a low dose non-add-back therapy (ABT) option. ObsEva said that it is also working closely with the European Medicine Agency's to achieve marketing approval. Linzagolix previously received validation of the marketing authorization application (MAA) with an approval recommendation from the Committee for Medicinal Products for Human Use expected in the fourth-quarter 2021. For comments and feedback contact: editorial@rttnews.com Business News
ObsEva SA(OBSV)周三表示,它已经向美国食品药品监督管理局提交了一份用于治疗子宫肌瘤的新药申请。 Linzagolix是一种口服GnRH受体拮抗剂,具有潜在的同类最佳疗效,良好的耐受性,以及独特和灵活的剂量选择。此外,如果获得批准,linzagolix将是子宫肌瘤中唯一一种低剂量非加减治疗(ABT)的GnRH拮抗剂。 ObsEva表示,它也在与欧洲药品管理局密切合作,以获得上市批准。Linzagolix此前收到了营销授权申请(MAA)的验证,并获得了人类使用药物产品委员会的批准建议,预计将于2021年第四季度提交。 如需评论和反馈,请联系:editorial@rttnews.com 商业新闻

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