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 (NASDAQ: AZN) and FibroGen Inc's (NASDAQ: 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 (NASDAQ: AMGN) and Johnson & Johnson's (NYSE: 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.
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