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Affymax, Inc. Message Board

  • dinepat203 dinepat203 Mar 4, 2013 3:03 PM Flag

    AFFY - EMA approval coming soon ..

    PharmaLive, Takeda Pharmaceuticals has received confirmation of receipt by the European Medicine Agency, of the “marketing authorisation application (MAA)” for peginesatide for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) 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) which results in the increased formation of red blood cells The MAA is based on two phase III trials (EMERALD 1 and 2),