Peginesatide (Omontys)
Overview
Peginesatide is a synthetic pegylated peptide-based erythropoiesis-stimulating agent (ESA) consisting of two 21-amino acid chains linked to polyethylene glycol. Unlike recombinant erythropoietin, it contains no erythropoietin sequence homology yet activates the erythropoietin receptor to stimulate red blood cell production. The pegylation confers a prolonged half-life, enabling once-monthly dosing in dialysis-dependent chronic kidney disease.
Key Research Findings
The FDA approved peginesatide in March 2012 for treatment of anemia in adult dialysis-dependent chronic kidney disease patients, based on two Phase 3 trials (EMERALD 1 and 2) demonstrating non-inferiority to darbepoetin alfa. The manufacturer voluntarily withdrew peginesatide from the U.S. market in February 2013 following reports of serious hypersensitivity reactions including anaphylaxis and deaths.
Intravenous, Subcutaneous injection
FDA Approved
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