AstraZeneca, FibroGen: FDA To Convene Committee Meeting To Review Roxadustat In Anaemia Of CKD

阿斯利康、Fibrogen:FDA召开委员会会议审查罗沙度他在CKD贫血中的应用

2021-03-02 18:46:24 RTTNews

本文共601个字,阅读需2分钟

AstraZeneca Plc. announced Tuesday that the US Food and Drug Administration or FDA informed FibroGen, Inc. that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application for roxadustat. Roxadustat is under regulatory review for the treatment of anaemia of chronic kidney disease or CKD in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients.. AstraZeneca said the company and FibroGen are working with the FDA ahead of the meeting and to bring roxadustat to patients with anaemia of CKD. A date for the advisory committee meeting has not been determined. AstraZeneca and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in the US, China and other countries in the Americas, Australia and New Zealand, as well as Southeast Asia. Further, FibroGen and Astellas are in development and commercialisation deal for roxadustat for the potential treatment of anaemia in Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa. The efficacy and safety of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, have been demonstrated in the pivotal Phase III programme and published in five peer-reviewed journals. The Phase III programme included more than 8,000 patients and was conducted by AstraZeneca, FibroGen and Astellas. Roxadustat is approved in China, Japan and Chile for the treatment of anaemia in CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients, and is under regulatory review in the EU and other jurisdictions. In the after hours trading on Nasdaq, FibroGen shares were losing around 20.6 percent. For comments and feedback contact: editorial@rttnews.com Business News
阿斯利康公司。美国食品和药物管理局星期二宣布,美国食品和药物管理局或FDA通知FibroGen公司,它将召开一次心血管和肾脏药物咨询委员会会议,审查罗沙度他的新药申请。 罗沙度他用于治疗非透析依赖型(NDD)和透析依赖型(DD)患者的慢性肾脏病贫血或CKD正在接受监管审查。 阿斯利康表示,该公司和FibroGen正在与FDA合作,在会议之前,将罗沙度他用于CKD贫血患者。咨询委员会会议的日期尚未确定。 阿斯利康和FibroGen正在美国、中国和其他美洲国家、澳大利亚、新西兰以及东南亚合作开发和商业化罗沙度他,用于治疗贫血。 此外,FibroGen和Astellas正在开发和商业化罗沙度他,用于在日本、欧洲、土耳其、俄罗斯和独立国家联合体、中东和南非治疗贫血症。罗沙度他是一种口服低氧诱导因子脯氨酰羟化酶(HIF-PH)抑制剂,其有效性和安全性已在pivotal III期项目中得到证实,并发表在五份同行评审期刊上。第三阶段方案包括8000多名患者,由阿斯利康、FibroGen和Astellas实施。罗沙度他在中国、日本和智利被批准用于治疗非透析依赖性(NDD)和透析依赖性(DD)成人患者的CKD贫血,并正在欧盟和其他司法管辖区接受监管审查。在纳斯达克的盘后交易中,FibroGen的股价下跌了约20.6%。 如需评论和反馈,请联系:editorial@rttnews.com 商业新闻

以上中文文本为机器翻译,存在不同程度偏差和错误;偶尔因源网页结构局限,内容无法一次完整呈现。请理解并参考原站原文阅读。

阅读原文