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FDA Rejects Akebia Therapeutics' Vadadustat For CKD-Associated Anemia

FDA Rejects Akebia Therapeutics' Vadadustat For CKD-Associated Anemia

FDA拒絕木通治療CKD相關性貧血的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已經發布了一封完整的回覆信(CRL)木通治療公司(納斯達克代碼：AKBA)用於治療慢性腎臟疾病所致貧血的伐多司特的營銷申請(NDA)。
  • 伐他定是一種研究中的口服缺氧誘導因子脯氨酸羥化酶(HIF-PH)抑制劑。
  • FDA發佈CRL，表明申請的審查週期已經完成，該申請目前的形式還沒有準備好批准。
  • FDA的結論是，營銷申請中的數據並不支持對透析和非透析患者進行有利的vadustat益處-風險評估。
  • FDA表達了安全方面的擔憂，注意到非透析患者羣體的MACE未能達到非劣勢，透析患者血管通路血栓形成導致血栓栓子事件的風險增加，以及藥物導致肝損傷的風險。
  • CRL表示，木通可能會探索通過新的臨牀試驗進行有利的益處-風險評估的方法。
  • 2021年10月，Akebia的合作伙伴，大冢控股有限公司(場外交易代碼：OTSKY)，提交了vadustat在歐洲的初步營銷申請。審查工作正在進行中。
  • 在日本，vadustat被批准用於治療依賴透析和不依賴透析的成人患者的慢性腎臟病所致的貧血。
  • 價格行動：AKBA股價週三最後一次收盤時下跌67.60%，至0.79美元。
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