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FDA Rejects Akebia Therapeutics' Vadadustat For CKD-Associated Anemia

FDA Rejects Akebia Therapeutics' Vadadustat For CKD-Associated Anemia

FDA拒绝木通治疗CKD相关性贫血的Vadadustat
Benzinga Real-time News ·  2022/03/30 15:36
  • The FDA has issued a complete response letter (CRL) to Akebia Therapeutics Inc's (NASDAQ:AKBA) marketing application (NDA) for vadadustat for anemia due to chronic kidney disease (CKD). 
  • Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor.
  • The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.
  • The FDA concluded that the data in the marketing application does not support a favorable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients. 
  • The FDA expressed safety concerns noting failure to meet non-inferiority in MACE in the non-dialysis patient population, the increased risk of thromboembolic events driven by vascular access thrombosis in dialysis patients, and the risk of drug-induced liver injury. 
  • The CRL stated that Akebia could potentially explore ways to potentially demonstrate a favorable benefit-risk assessment through new clinical trials. 
  • In October 2021, Akebia's collaboration partner, Otsuka Holdings Co Ltd (OTC:OTSKY), submitted an initial marketing application for vadadustat in Europe. The review is ongoing. 
  • In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis-dependent adult patients.
  • Price Action: AKBA shares are down 67.60% at $0.79 on the last check Wednesday.
  • FDA已经发布了一封完整的回复信(CRL)木通治疗公司(纳斯达克代码：AKBA)用于治疗慢性肾脏疾病所致贫血的伐多司特的营销申请(NDA)。
  • 伐他定是一种研究中的口服缺氧诱导因子脯氨酸羟化酶(HIF-PH)抑制剂。
  • FDA发布CRL，表明申请的审查周期已经完成，该申请目前的形式还没有准备好批准。
  • FDA的结论是，营销申请中的数据并不支持对透析和非透析患者进行有利的vadustat益处-风险评估。
  • FDA表达了安全方面的担忧，注意到非透析患者群体的MACE未能达到非劣势，透析患者血管通路血栓形成导致血栓栓子事件的风险增加，以及药物导致肝损伤的风险。
  • CRL表示，木通可能会探索通过新的临床试验进行有利的益处-风险评估的方法。
  • 2021年10月，Akebia的合作伙伴，大冢控股有限公司(场外交易代码：OTSKY)，提交了vadustat在欧洲的初步营销申请。审查工作正在进行中。
  • 在日本，vadustat被批准用于治疗依赖透析和不依赖透析的成人患者的慢性肾脏病所致的贫血。
  • 价格行动：AKBA股价周三最后一次收盘时下跌67.60%，至0.79美元。
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