Ahead Of AdComm AstraZeneca, FibroGen's Roxadustat Hit With Safety, Efficacy Questions

Ahead of Thursday's meeting of the FDA's Cardiovascular and Renal Drugs Advisory Committee, the agency is raising fresh doubts on the safety of AstraZeneca Plc's AZN and FibroGen Inc's FGEN anemia drug roxadustat.
FDA staffers flagged concerning evidence of blood clotting, when compared with placebo in nondialysis-dependent patients but also when compared against Amgen Inc AMGN and Johnson & Johnson's JNJ Epogen/Procrit, "which is itself known to pose these risks," in dialysis-dependent patients.
The staffers pooled their safety analysis from six Phase 3 trials in non-dialysis and dialysis-dependent patients.
On a composite of major adverse cardiac events (MACE), roxadustat was comparable to Epogen/Procrit in dialysis-dependent patients and comparable to placebo among non-dialysis patients.
The agency also noted "considerable disparity in subject retention between the roxadustat and placebo groups," challenging the interpretation of the company's safety analyses.
The committee on Thursday will be tasked with voting on two approval questions: whether roxadustat should be approved for the treatment of anemia due to CKD in adult patients on dialysis and whether it should be approved for those not on dialysis.
See the FDA Briefing Documents here.
Price Action: FGEN shares are down 4.7% at $24.19, and AZN stock is down 0.14% at $60.41 during the market session on the last check Tuesday.
Related content: Benzinga's Full FDA Calendar.