FibroGen has staked another claim to market for a new class of oral therapies for anemia associated with chronic kidney disease (CKD), after reporting a positive phase 3 trial. Roxadustat currently leading the pack in the hypoxia-inducible factor (HIF) stabilizer category met its objectives in the ALPS study, the first of three late-stage European studies being conducted by FibroGen’s partner Astellas.
The drug outperformed placebo in its ability to boost hemoglobin (Hb) levels, significantly improving the Hb response rate in the first 24 weeks after starting treatment in patients not requiring dialysis, and Hb changes from baseline in weeks 28 to 52. Astellas, which also has trials ongoing in CKD patients on dialysis, said the study is another step toward filing and reimbursement of the drug in Europe.