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

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

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

  | Ref: Globe Newswire | Image: Fibrogen

Click here to­ read the full press release 

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