Peginesatide

Peginesatide
Clinical data
Trade namesOmontys
AHFS/Drugs.comOmontys
License data
Routes of
administration		Subcutaneous, intravenous
ATC code
Legal status
Legal status
Identifiers
  • Poly(oxy-1,2-ethanediyl), α-hydro-ω-methoxy-, diester with 21N6,21'N6-{[(N2,N6-dicarboxy-L-lysyl-β-alanyl)imino]bis(1-oxo-2,1-ethanediyl)}bis[N-acetylglycylglycyl-L-leucyl-L-tyrosyl-L-alanyl-L-cysteinyl-L-histidyl-L-methionylglycyl-L-prolyl-L-isoleucyl-L-threonyl-3-(1-naphthalenyl)-L-alanyl-L-valyl-L-cysteinyl-L-glutaminyl-L-prolyl-L-leucyl-L-arginyl-N-methylglycyl-L-lysinamide] cyclic (6→15),(6'→15')-bis(disulfide)[1]
CAS Number
PubChem SID
IUPHAR/BPS
ChemSpider
  • none
UNII
KEGG
ChEBI
Chemical and physical data
FormulaC231H350N62O58S6[C2H4O]n
Molar mass45 kg/mol

Peginesatide[2] (INN/USAN, trade name Omontys, formerly Hematide), developed by Affymax and Takeda, is an erythropoietic agent, a functional analog of erythropoietin.

It was approved by the U.S. Food and Drug Administration for treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis.[3][4] On February 23, 2013, Affymax and Takeda issued a press release indicating that they were recalling all batches of peginesatide from the market.[5] On June 16, 2014, Affymax and Takeda issued a press release stating that Takeda will work with the FDA to withdraw the peginesatide New Drug Application.[6]

Two randomized controlled trials published in 2013 found that the effectiveness of peginesatide was not inferior to epoetin for patients receiving dialysis (the EMERALD study),[7] or to darbepoetin for patients with chronic kidney disease who were not receiving dialysis (the PEARL study).[8] However, the safety endpoint of cardiovascular events and death was worse for peginesatide than for darbepoetin in the PEARL study.

  1. ^ Cite error: The named reference USAN was invoked but never defined (see the help page).
  2. ^ Cite error: The named reference Affymax was invoked but never defined (see the help page).
  3. ^ Cite error: The named reference omontyssitehp was invoked but never defined (see the help page).
  4. ^ Cite error: The named reference FDAapproval was invoked but never defined (see the help page).
  5. ^ FDA alerts health care providers of recall of anemia drug Omontys. U.S. Food and Drug Administration [1]
  6. ^ Affymax and Takeda Announce Termination of Omontys® (peginesatide) Product Collaboration and License Agreement. Takeda will withdraw the Omontys U.S. New Drug Application (NDA)[2]
  7. ^ Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A (January 2013). "Peginesatide in patients with anemia undergoing hemodialysis". N. Engl. J. Med. 368 (4): 307–19. doi:10.1056/NEJMoa1203165. hdl:10486/664909. PMID 23343061.
  8. ^ Macdougall IC, Provenzano R, Sharma A, Spinowitz BS, Schmidt RJ, Pergola PE, Zabaneh RI, Tong-Starksen S, Mayo MR, Tang H, Polu KR, Duliege AM, Fishbane S (January 2013). "Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis". N. Engl. J. Med. 368 (4): 320–32. doi:10.1056/NEJMoa1203166. PMID 23343062.