Affymax, Inc. (NASDAQ:AFFY) and Takeda Pharmaceutical Company Limited (TSE: 4502, "Takeda") today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational agent peginesatide (formerly known as Hematide™) for the treatment of anemia associated with chronic renal failure (CRF) in adult patients on dialysis.
Peginesatide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA). The agent is being co-developed by Affymax and Takeda. The NDA includes data from two Phase 3 studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels), in maintaining hemoglobin (Hb) levels. In the studies, CRF patients on dialysis who were receiving stable doses of epoetin, were randomized to receive once-monthly peginesatide or continue treatment with epoetin. The EMERALD findings suggested that once-monthly peginesatide was similar to epoetin in maintaining Hb levels in CRF patients on dialysis with anemia with a similar adverse event rate.
"The submission of the peginesatide NDA is an important milestone for Affymax and the result of dedication and diligence by both the Affymax and Takeda teams," said John Orwin, chief executive officer, Affymax. "Anemia is a debilitating condition for chronic renal failure patients on dialysis, and our program illustrates the potential of peginesatide as an important once-monthly therapeutic option for patients and providers, if approved. We look forward to working with the FDA as they review the data package for the peginesatide New Drug Application."
"We're pleased to have partnered with Affymax on a submission that includes data from the largest Phase 3 program to support the initial registration of an ESA for the treatment of anemia of chronic renal failure and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events," said Azmi Nabulsi, M.D., M.P.H, president of Takeda Global Research & Development Center, Inc. U.S. "To date, limited options for treating anemia in chronic renal failure patients on dialysis exist. The peginesatide New Drug Application represents an important step in the evaluation of a potentially new treatment for this common condition in chronic renal failure."
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