Affymax, Inc. (Nasdaq:AFFY) today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011 during the afternoon session. The FDA has established an action date of March 27, 2012 under the Prescription Drug User Fee Act (PDUFA).
Erythropoiesis stimulating agents (ESAs) are reviewed by the Office of Hematology and Oncology Products (OHOP). As such, FDA has designated ODAC for the review of peginesatide. Information related to the meeting can be found on the U.S. Office of the Federal Register Website at: http://www.fda.gov/RegulatoryInformation/Dockets/FR/default.htm.
The company intends to begin a self-imposed quiet period on November 16, 2011 in anticipation of receipt of FDA briefing documents, and this quiet period will continue until after the Advisory Committee meeting is completed.
If approved, peginesatide will be the first once-monthly ESA available for the treatment of anemia associated with CKD patients on dialysis in the United States.
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