Daniel Coyne @DrDanMO · 1h My #Roxadustat FDA predictions.. 1. Black box stays 2. Approved in both CKD-ND and -DD 3. Hgb target is <11 and don’t start if Hgb is >10 g/dL; lower #ROXA start dose 4. Require a Phase 4 outcomes CKD-ND trial vs ESA with Hb target 10-11 g/dL. Ideally, with eGFR >15, and <45.
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