After FDA Rejection, EMA Approves FibroGen-Astellas' Roxadustat

  • The European Commission (EC) has approved FibroGen Inc FGEN and Astellas Pharma's ALPMF Evrenzo (roxadustat) for anemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug.
  • Related: FDA Shoots Down Roxadustat Application, Asks For Additional Trial.
  • The approval makes Evrenzo (roxadustat) the first oral HIF-PH inhibitor to be cleared for use in the EU, ahead of rival candidates daprodustat from GlaxoSmithKline plc GSK and Akebia Therapeutics Inc's AKBA vadadustat.
  • The Commission has approved the drug for use in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) CKD patients, providing an oral alternative to injectable erythropoiesis-stimulating agents (ESAs).
  • The EU approval triggers a $120 million milestone payment from Astellas to FibroGen.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: FGEN shares are up 5.41% at $12.09 during the premarket session on the last check Friday.
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