Affymax, Inc. and Takeda Pharmaceutical Company Limited announced that following pre-New Drug Application (NDA) discussions with the US Food and Drug Administration (FDA), the companies will move forward with their regulatory strategy for the investigational drug, peginesatide, for the treatment of anaemia in chronic renal failure (CRF) patients on dialysis in the United States.
"Our plan is to pursue approval of peginesatide for the treatment of anaemia 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 anaemia in chronic renal failure patients on dialysis in the second quarter of 2011."
Azmi Nabulsi, MD, MPH, president of Takeda Global Research & Development Centre, Inc., US added, "Anaemia is a common consequence of chronic kidney disease (CKD) or chronic renal failure (CRF) that can occur in patients on dialysis. Our goal with peginesatide, upon approval, is to provide a new therapeutic option to the physicians and dialysis patients who are challenged with managing anaemia associated with CRF."
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 anaemia associated with CRF. The product, upon approval, will be commercialized outside the United States by Takeda.
Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.