Peginesatide

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 B03XA04 (WHO)
Legal status
Legal status
Identifiers
CAS Number 913976-27-9
1185870-58-9 (acetate)
PubChem (SID) 124490628
IUPHAR/BPS 7447
ChemSpider none
ChEBI CHEBI:66889 YesY
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

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

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.

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, however United States patent law currently forbids their sale.[10]

References

  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
  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)
  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. 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.
  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. doi:10.1182/blood-2006-04-015818. PMID 16720830.
  10. ↑ "Judge blocks anemia drug sales by Amgen Rival". New York Times. February 29, 2008.

Further reading

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