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