Regulatory Affairs

FDA accepts NDA to review Affymax, Takeda chronic kidney disease drug

PBR Staff Writer Published 28 July 2011

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.