FDA Advisory Committee Votes Favorably on the Question of the Effectiveness and Safety of Pretomanid in Combination with Bedaquiline and Linezolid for Treatment of Highly Drug-Resistant Forms of Tuberculosis

Pretomanid联合Bedaquiline和Linezolid治疗高度耐药结核病有效性获FDA认可

2019-06-10 14:08:00 CISION

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TB Alliance announced today that the U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee voted that there is substantial evidence of the effectiveness and sufficient evidence of the safety of pretomanid as part of a combination regimen with bedaquiline and linezolid, in adults for the treatment of pulmonary extensively drug resistant or treatment-intolerant or nonresponsive multidrug-resistant tuberculosis. Pretomanid, an investigational anti-TB drug, is the subject of a New Drug Application (NDA) currently under Priority Review by the FDA and a Marketing Authorization Application under review by the European Medicines Agency. It has been developed by TB Alliance, a non-profit drug developer, as part of an all-oral combination therapy known as the BPaL regimen (comprised of bedaquiline, pretomanid and linezolid). "We are encouraged by the advisory committee's vote in favor of pretomanid for use in combination with bedaquiline and linezolid for the treatment of highly-resistant forms of TB and we look forward to the FDA's final action," said Mel Spigelman, president and CEO of TB Alliance. The committee's vote was based on a review of safety and efficacy data from 19 clinical studies, including an interim analysis of the pivotal Phase 3 Nix-TB trial of subjects with XDR-TB or MDR-TB who were treatment-intolerant or non-responsive. A modified intent-to-treat analysis of Nix-TB data included in the regulatory submission indicated that treatment with the BPaL regimen resulted in a favorable outcome in 90 percent of patients after six months of treatment and six months of post-treatment follow-up. The advisory committee's non-binding vote is taken into consideration by the FDA as part of its evaluation of the NDA. The Prescription Drug User Fee Act (PDUFA) action date for an FDA decision is in August 2019.
结核病联盟今天宣布,美国食品药品监督管理局(Food and Drug Administration)抗微生物药物咨询委员会投票认为,有大量证据表明,作为贝达基隆和利奈唑胺联合养生法方案的一部分,预托马酸的有效性和足够的安全性证据,在成人中用于治疗肺广泛耐药或治疗不耐受或不敏感的多重耐药结核病。 Pretomanid ,一种研究中的抗结核药物,是目前由 FDA 进行优先审评的新药申请( NDA )和欧洲药品管理局正在审查的上市许可申请的主题。它是由一个非营利性的药物开发商结核联盟开发的,作为一种称为 BPaL 养生法的全口服联合治疗的一部分(包括贝达基林、妥美特罗和利奈唑胺)。 结核病联盟主席兼首席执行官 Mel Spigelman 说:“咨询委员会投票支持预托麦片用于治疗耐药结核病的贝达基林和利奈唑胺,我们对此感到鼓舞,我们期待 FDA 采取最终行动。” 该委员会的投票基于对19项临床研究的安全性和有效性数据的审查,包括对 XDR-TB 或 MDR-TB 患者治疗不耐受或不应答的关键3期 Nix-TB 试验的中期分析。在提交给监管机构的报告中对 Nix-TB 数据进行的一项经修改的意向治疗分析表明, BPaL 方案的治疗在治疗6个月后和治疗后6个月的随访中,90%的患者获得了良好的结果。 FDA 在评估 NDA 时考虑了咨询委员会的无约束力投票。FDA 决定的处方药用户费用法案( PDUFA )诉讼日期为2019年8月。

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