After FDA Rejection, EMA Approves FibroGen-Astellas' Roxadustat
- The European Commission (EC) has approved FibroGen Inc (NASDAQ: FGEN) and Astellas Pharma's (OTC: 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 (NYSE: GSK) and Akebia Therapeutics Inc's (NASDAQ: 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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