FDA accepts NDA to review Affymax, Takeda chronic kidney disease drug
The US Food and Drug Administration (FDA) has accepted for reviewing Affymax and Takeda Global Research & Development Center's new drug application (NDA) for peginesatide (Hematide) as a treatment for anemia associated with chronic kidney disease (CKD) in adult patients on dialysis.
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.