Affymax (AFFY), Takeda Get Positive ODAC Vote for Peginesatide on CKD
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Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 15 to 1, with 1 abstention, that peginesatide demonstrated a favorable benefit/risk profile for use in the treatment of dialysis patients with anemia due to chronic kidney disease (CKD).
While the FDA is not bound by the recommendations of its advisory committees, their guidance will be considered by the FDA in its review of the New Drug Application (NDA) that was submitted for peginesatide in May 2011. The scheduled Prescription Drug User Fee Act (PDUFA) date for peginesatide is March 27, 2012.
While the FDA is not bound by the recommendations of its advisory committees, their guidance will be considered by the FDA in its review of the New Drug Application (NDA) that was submitted for peginesatide in May 2011. The scheduled Prescription Drug User Fee Act (PDUFA) date for peginesatide is March 27, 2012.
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