PALO ALTO, Calif. –The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for Affymax’s peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on Dec. 7, 2011, during the afternoon session.
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.
Affymax said in a news release it intends to begin a self-imposed quiet period on Nov. 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, according to Affymax.
