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news.Affymax and Takeda Pharmaceutical Company said that they will move forward with their regulatory strategy for the investigational drug, Hematide / peginesatide, for the treatment of anemia in chronic renal failure (CRF) patients on dialysis in the US, following pre-new drug application (NDA) discussions with the US Food and Drug Administration (FDA).
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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 to develop peginesatide and plan to co-commercialise the product once approved in the US.
Phase 3 clinical trials investigated the potential for peginesatide to treat anemia associated with chronic renal failure. The product, upon approval, will be commercialised outside the US by Takeda.
Affymax CEO Arlene Morris said that based on their meeting with FDA, they believe the data from the completed trials are sufficient for review of their 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," Morris said.
Takeda Global Research & Development Center president Azmi Nabulsi said that their 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.