PALO ALTO, Calif.—Affymax and Takeda Pharmaceutical announced Nov. 29 that following pre-New Drug Application (NDA) discussions with the U.S. Food and Drug Administration (FDA), the companies will move forward with their regulatory strategy for the investigational drug, peginesatide, for the treatment of anemia in chronic renal failure (CRF) patients on dialysis in the United States.
"Our plan is to pursue approval of peginesatide for the treatment of anemia in CRF patients on dialysis," said Arlene M. Morris, chief executive officer of Affymax. "Based on our meeting with FDA, we believe the data from our completed trials are sufficient for review of our NDA for this indication. Our goal is to submit the NDA for peginesatide for the treatment of anemia in chronic renal failure patients on dialysis in the second quarter of 2011."
Peginesatide is a novel investigational synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA.
Affymax and Takeda are collaborating on the development of peginesatide and plan to co-commercialize the product once approved in the United States. Phase 3 clinical trials investigated the potential for peginesatide to treat anemia associated with chronic renal failure. The product, upon approval, will be commercialized outside the United States by Takeda.
"Anemia is a common consequence of chronic kidney disease or chronic renal failure that can occur in patients on dialysis,” said Azmi Nabulsi, MD, MPH, president of Takeda Global Research & Development Center. “Our goal with peginesatide, upon approval, is to provide a new therapeutic option to the physicians and dialysis patients who are challenged with managing anemia associated with chronic renal failure."
