Affymax Announces Assignment of March 27, 2012 PDUFA Date for Peginesatide New Drug Application

Affymax, Inc. AFFY today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act action date of March 27, 2012 for the review of the investigational agent peginesatide (formerly known as Hematide™) New Drug Application. The company had announced on July 27, 2011 that the FDA accepted the peginesatide NDA submission for review. 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 United States.