Affymax, Inc. (AFFY) and Takeda Global Research & Development Center, Inc., U.S., announced that the U.S. Food and Drug Administration, or FDA, accepted for review the New Drug Application, or NDA, for peginesatide for the treatment of anemia associated with chronic kidney disease, or CKD, in adult patients on dialysis.
According to Affymax, if approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent available for the treatment of anemia associated with CKD patients on dialysis in the US.
Peginesatide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA.
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