Peginesatide Overview
Peginesatide (formerly known as Hematide™) is an investigational (not yet approved for use) erythropoiesis-stimulating agent (ESA) that is being tested in clinical trials for the treatment of anemia associated with chronic kidney disease (CKD). The investigational therapy, co-developed by Affymax (Palo Alto, CA) and Takeda (Osaka, Japan), has been investigated in Phase 3 studies in patients with CKD. In patients with CKD, these trials evaluated the ability of peginesatide to correct anemia by raising and maintaining hemoglobin (Hgb) levels within a target of 10-12 g/dL in dialysis patients and 11-12 g/dL in non-dialysis patients. Preliminary top-line results from the Phase 3 clinical program were announced in June 2010 (click here for press release). A New Drug Application (NDA) for peginesatide for the treatment of anemia associated with CKD in adult patients on dialysis is currently being reviewed by the U.S. Food and Drug Administration (FDA) (click here for press release).
Peginesatide is a novel, synthetic peptide-based ESA that is immunologically distinct from endogenous human erythropoietin (EPO), a protein produced by the kidneys to stimulate the production of oxygen- transporting red blood cells. The most advanced portion of peginesatide's clinical development program is a Phase 3 program that consisted of four studies studies including two in dialysis patients (EMERALD 1 and 2) and two in non-dialysis patients (PEARL 1 and 2) involving approximately 2,600 patients across almost 400 clinical sites in U.S. and Europe.
Takeda and Affymax are collaborating on the development of peginesatide and plan to co-commercialize the product in the United States. The product, upon approval, will be commercialized in the European Union by Takeda.
Peginesatide is the USAN or nonproprietary name for the compound.