Peginesatide

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Peginesatide
Clinical data
Trade names Omontys
AHFS/Drugs.com Omontys
License data
Pregnancy
category
  • US: C (Risk not ruled out)
Routes of
administration
Subcutaneous, intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem SID
IUPHAR/BPS
ChemSpider
  • none
KEGG
ChEBI
Chemical and physical data
Formula C231H350N62O58S6[C2H4O]n
Molar mass 45 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.

Medical uses[edit]

The FDA approved the use of peginesatide for the treatment of anemia due to chronic kidney disease in adult patients on dialysis.

Chemistry and mechanism of action[edit]

Peginesatide is a synthetic peptide, attached to polyethylene glycol ("PEGylated").[9] It mimics the structure of erythropoietin, the human glycoprotein which promotes red blood cell development.

Related drugs[edit]

The erythropoietin analogs currently used to treat anemia in the United States are epoetin alfa (sold under the names Procrit and Epogen) and darbepoetin alfa (which is a more glycosylated form of epoetin, sold under the name Aranesp). There are similar biologic agents, such as Mircera (a monoPEGylated erythropoietin-beta), sold by Roche in Europe, Chugai in Japan, and VFMCRP in the United States.

References[edit]

  1. ^ Statement On A Nonproprietary Name Adopted By The USAN Council: Peginesatide
  2. ^ "Affymax, Inc Homepage". Retrieved December 7, 2011. 
  3. ^ "Omontys (peginesatide): Official site for US physicians". Affymax and Takeda. Retrieved April 29, 2012. 
  4. ^ Yao S (March 27, 2012). "FDA approves Omontys to treat anemia in adult patients on dialysis" (press release). US FDA. Retrieved April 29, 2012. 
  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. PMID 23343061. doi:10.1056/NEJMoa1203165. 
  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. PMID 23343062. doi:10.1056/NEJMoa1203166. 
  9. ^ Stead RB, Lambert J, Wessels D, Iwashita JS, Leuther KK, Woodburn KW, Schatz PJ, Okamoto DM, Naso R, Duliege AM (September 2006). "Evaluation of the safety and pharmacodynamics of Hematide, a novel erythropoietic agent, in a phase 1, double-blind, placebo-controlled, dose-escalation study in healthy volunteers". Blood. 108 (6): 1830–4. PMID 16720830. doi:10.1182/blood-2006-04-015818. 

Further reading[edit]