One To Watch: Ruling On AZ’s First-In-Class Anemia Drug Roxadustat Expected Shortly
Label Warning Will Be Key
AstraZeneca is in pole position to open up the HIF-PH inhibitor market – but GSK has a rival in the wings.
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AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.
Comment: While the travails around the COVID-19 vaccine continue, AstraZeneca has plenty in its pipeline to cheer investors.
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.