Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE, 4502), today announced 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”
"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."
Azmi Nabulsi, M.D., M.P.H, president of Takeda Global Research & Development Center, Inc., U.S. added, "Anemia is a common consequence of chronic kidney disease or chronic renal failure 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 anemia associated with chronic renal failure."
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