Peginesatide, a synthetic, PEGylated peptidic compound, is a erythropoiesis stimulating agent (ESA) that binds and activates the erythropoietin receptor.
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 anemia.