The US FDA’s Rejects FibroGen’s Roxadustat for the Treatment of Anemia Due to CKD

August 11, 2021 Auto Bot Anemia, FDA, FibroGen, regulatory 0

Shots:

  • The company has received an FDA’s CRL declining the approval of roxadustat’s NDA to treat anemia of CKD
  • The FDA has requested to conduct an additional clinical study of roxadustat before resubmission
  • The therapy is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in both NDD and DD adult patients and has received a CHMP’s positive opinion. The company is expecting the EC’s decision at the end of Aug’21

Click here to­ read full press release/ article | Ref: Globe Newswire | Image: Fibrogen

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