Peginesatide

Hematology

Also known as: Omontys, Hematide

EPO Mimetic PeptidesResearch phase: WithdrawnRegulatory: FDA-approved 2012, voluntarily withdrawn 2013 due to fatal anaphylaxis.

Mechanism

Peginesatide was a synthetic peptide that mimicked erythropoietin (EPO) to treat anemia in dialysis patients. It was FDA-approved in 2012 but withdrawn in 2013 due to fatal anaphylaxis reactions.

Technical detail

Peginesatide is a PEGylated synthetic dimeric peptide with no sequence homology to EPO that activates the EPO receptor (EPOR), stimulating erythropoiesis. FDA-approved March 2012 (Omontys) for anemia in dialysis-dependent CKD patients. Voluntarily withdrawn February 2013 after post-marketing reports of serious hypersensitivity/anaphylaxis (0.02% incidence, including fatalities), attributed to the PEG moiety or formulation.

Evidence

  • Peginesatide in patients with anemia undergoing hemodialysis.

    Fishbane et al. (2013) — N Engl J Med — PMID: 23343061

    EMERALD 1 and 2 randomized studies in hemodialysis patients showed once-monthly peginesatide was noninferior to epoetin for maintaining hemoglobin over 52 weeks or longer, establishing efficacy for dialysis-associated anemia despite broader safety concerns that later limited its use.

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