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news.Affymax and Takeda Pharmaceutical have filed a new drug application (NDA) for experimental drug peginesatide (formerly known as Hematide) as the treatment for anemia linked with chronic renal failure (CRF) in adult patients on dialysis, with the US Food and Drug Administration (FDA).
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Jointly developed by Affymax and Takeda, 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 filing of the NDA was done on the basis of the results from two Phase 3 (EMERALD 1 and 2) studies that investigated the safety and efficacy of peginesatide, dosed once every four weeks, in comparison to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels), in maintaining hemoglobin (Hb) levels.
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.
Affymax CEO John Orwi said 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.
"We look forward to working with the FDA as they review the data package for the peginesatide New Drug Application," Orwi said.