FDA accepts NDA to review Affymax, Takeda chronic kidney disease drug - Pharmaceutical Business Review PDF Print
Pharmaceutical Business Review
The NDA submission is based on data from two Phase 3 studies (Emerald 1 and 2) which evaluated the efficacy and safety of peginesatide. The study compared once-monthly peginesatide with epoetin in maintaining Hb levels in CKD patients on dialysis with

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