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.

See more from Benzinga

• Click here for options trades from Benzinga

• Oxford-Led Study Shows Efficacy Of COVID-19 Vaccines Dwindles Over Time Against Delta Variant

• Compugen's Out-Licensed Lung Cancer Candidate Enters Human Trial

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.