FibroGen Announces Positive Topline Results from Pooled Safety Analyses of Roxadustat Global Phase 3 Program
FibroGen, Inc (FGEN)
Last fibrogen, inc earnings: 3/2 04:01 pm
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Source: GlobeNewswire
SAN FRANCISCO, May 09, 2019 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced topline results from the pooled safety analyses of the global Phase 3 program for roxadustat, an inhibitor of hypoxia-inducible-factor (HIF) prolyl hydroxylase activity (HIF-PHI). The global pivotal Phase 3 trials were conducted by FibroGen and collaboration partners AstraZeneca and Astellas Pharma, Inc., for treatment of anemia in chronic kidney disease (CKD) patients across the non-dialysis-dependent (NDD), incident (newly initiated) dialysis, and dialysis-dependent (DD) CKD populations, enrolled from more than 50 countries. These pooled analyses of adjudicated events for safety assessment of roxadustat are part of the overall benefit-risk assessment. For the planned new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA), one of the key safety endpoints to be evaluated is Major Adverse Cardiac Events (MACE), a composite endpoint of all-cause mortality, str
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- FGEN's page on the SEC website