The US Food & Drug Administration’s upcoming advisory committee review of AstraZeneca PLC and FibroGen, Inc.’s roxadustat for treatment of anemia in patients with chronic kidney disease may facilitate comparisons of the first-in-class agent with erythropoiesis-stimulating agents, a long-time standard of care.
AstraZeneca/FibroGen’s Roxadustat Comparison To ESAs In Anemia May By Clarified At FDA Advisory Cmte.
Payers would welcome any additional clarity provided by advisory panel review, given the perception, expressed in a recent ICER report, that the evidence is insufficient to determine whether the new drug is safer or more effective than erythropoiesis-stimulating agents.
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