FibroGen Shares Are Trading Lower As FDA Shoots Down Roxadustat Application, Asks For Additional Trial - AstraZeneca (NASDAQ:AZN), Astellas Pharma (OTC:ALPMY), Astellas Pharma (OTC:ALPMF), FibroGen (NASDAQ:FGEN)

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.