FDA rejects AstraZeneca-FibroGen’s roxadustat for CKD-related anaemia

FDA拒绝阿斯利康-纤维原的罗沙度他治疗CKD相关性贫血

2021-08-12 17:30:15 PHARMACEUTICAL

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The US Food and Drug Administration has declined to approve AstraZeneca and FibroGen’s new drug application for roxadustat to treat anaemia associated with chronic kidney disease . The application is for the use of roxadustat in adult non-dialysis dependent (NDD) and dialysis-dependent (DD) patients. FDA issued a complete response letter (CRL) to AstraZeneca and FibroGen, requesting an additional clinical study to check the safety of roxadustat in NDD and DD patients before the resubmission of NDA. Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that promotes erythropoiesis, or red blood cell production. AstraZeneca stated that the safety and efficacy of roxadustat have already been tested in the Phase III programme, which was performed in more than 8,000 patients. Carried out by AstraZeneca, FibroGen and Astellas Pharma, this programme comprised the OLYMPUS, ALPS and ANDES trials that compared roxadustat to placebo in NDD-CKD patients. The programme also involved the ROCKIES, SIERRAS and HIMALAYAS trials, which assessed roxadustat versus epoetin alfa in DD-CKD and incident dialysis patients. The drug is approved in several countries, including China, Chile, South Korea and Japan under the name Evrenzo, to treat anaemia associated with CKD in both NDD and DD adult patients. In Europe, Astellas submitted the marketing authorisation application for Evrenzo to treat this patient population. The European Medicines Agency (EMA) accepted the application for review in May last year. In June this year, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of roxadustat, which is currently under final regulatory review. Astellas and AstraZeneca also submitted many other licensing applications for the drug to regulatory authorities globally. Furthermore, the drug is in clinical development for the treatment of anaemia related to myelodysplastic syndromes (MDS) and for chemotherapy-induced anaemia (CIA).
美国食品药品监督管理局(FDA)拒绝批准阿斯利康和Fibrogen的罗沙度他治疗慢性肾病(CKD)相关贫血的新药申请(NDA)。 本申请用于成人非透析依赖(NDD)和透析依赖(DD)患者使用罗沙度他。 FDA向阿斯利康和FibroGen发布了一份完整的回应函(CRL),要求在重新提交NDA之前进行额外的临床研究,检查罗沙度他在NDD和DD患者中的安全性。 罗沙度他是一种口服低氧诱导因子脯氨酸羟化酶(HIF-PH)抑制剂,促进红细胞生成或红细胞生成。 阿斯利康表示,罗沙度他的安全性和有效性已经在第三阶段计划中进行了测试,该计划在8000多名患者中进行。 该项目由阿斯利康、FibroGen和Astellas Pharma进行,包括奥林匹斯山、阿尔卑斯山和安第斯山试验,将罗沙度司他与安慰剂在NDD-CKD患者中进行比较。 该项目还包括落基山脉、西拉斯和喜马拉雅山的试验,该试验评估了DD-CKD和偶发透析患者的罗沙度司他和埃博素阿尔法的对比。 该药物在包括中国、智利、韩国和日本在内的几个国家获得批准,以Evrenzo的名称治疗NDD和DD成人患者中与CKD相关的贫血。 在欧洲,Astellas提交了Evrenzo治疗这一患者群体的营销授权申请。欧洲药品管理局(EMA)去年5月接受了审查申请。 今年6月,欧洲药品管理局人用药品委员会(CHMP)建议批准罗沙度司他,目前正在进行最终监管审查。 Astellas和AstraZeneca还向全球监管机构提交了该药物的许多其他许可申请。 此外,该药物正在临床开发中,用于治疗与骨髓增生异常综合征(MDS)相关的贫血和化疗诱导的贫血(CIA)。

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