FibroGen looking to EU decision, new indications for roxadustat as FDA requests another trial

In the wake of a complete response letter in which FDA requested that FibroGen perform another clinical trial of roxadustat, the biotech is looking ahead to a European approval decision and readouts in two more indications as it and its partner AstraZeneca contemplate the drug’s future.

FibroGen Inc. (NASDAQ:FGEN) said Wednesday it will discuss next steps for the HIF-PH inhibitor with AstraZeneca plc (LSE:AZN; NYSE:AZN) following FDA’s decision on its NDA for roxadustat to treat anemia associated with chronic kidney disease...