The FDA’s Oncologic Drugs Advisory Committee, in a 15 to 1 vote, has agreed that peginesatide demonstrates a favorable benefit/risk profile for use in treatment of dialysis patients with anemia resulting from chronic kidney disease (CKD).
The FDA will consider the committee’s recommendation when reviewing a New Drug Application for peginesatide submitted in May as well as a Prescription Drug User Fee Act scheduled for March 2012. If approved, peginesatide will be the first once-monthly treatment available in the U.S. for CKD anemia patients on dialysis.
The phase 3 clinical program of peginesatide was the first to prospectively study the cardiovascular safety of an ESA by analyzing independently adjudicated cardiovascular events.
Peginesatide is a synthetic, PEGylated peptidic compound that stimulates erythropoietin receptors. It was discovered by Affymax, Inc. and is being co-developed by Takeda Pharmaceutical Company Ltd.