Affymax, Inc. (AFFY) said 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 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 (ESA) available for the treatment of anemia associated with CKD patients on dialysis in the United States.
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