FibroGen Shares Are Trading Lower As FDA Shoots Down Roxadustat Application, Asks For Additional Trial

  • The FDA has issued a complete response letter regarding the marketing application for FibroGen Inc's FGEN roxadustat for anemia of chronic kidney disease (CKD).
  • The letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested an additional clinical study of roxadustat be conducted.
  • Roxadustat is approved in China, Japan, Chile, and South Korea for CKD anemia in non-dialysis-dependent (NDD) and dialysis-dependent (DD) adult patients.
  • The product received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The European Commission decision is expected by the end of August.
  • Roxadustat is a HIF-PH inhibitor that promotes erythropoiesis or red blood cell production.
  • In July, FDA's Cardiovascular and Renal Drugs Advisory Committee voted 13-to-1 against approval of roxadustat for non-dialysis-dependent patients and 12-to-2 against approval for dialysis-dependent indications.
  • Astellas Pharma Inc ALPMF and AstraZeneca plc AZN are collaborating with Fibrogen to develop and commercialize roxadustat.
  • Price Action: FGEN shares are down 2.20% at $12.90 premarket on the last check Wednesday.
  • Related content: Benzinga's Full FDA Calendar.
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