Peginesatide: Difference between revisions

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==Overview==
==Overview==
'''Peginesatide'''<ref name="Affymax" /> ([[International Nonproprietary Name|INN]]/[[United States Adopted Name|USAN]], trade name '''Omontys''', formerly '''Hematide'''), developed by [[Affymax]] and [[Takeda Pharmaceutical Company|Takeda]], is an [[Erythropoiesis|erythropoietic]] agent, a [[functional analog]] of [[erythropoietin]].  
'''Peginesatide'''([[International Nonproprietary Name|INN]]/[[United States Adopted Name|USAN]], trade name '''Omontys''', formerly '''Hematide'''), developed by [[Affymax]] and [[Takeda Pharmaceutical Company|Takeda]], is an [[Erythropoiesis|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]].<ref name=omontyssitehp/><ref name=FDAapproval/> On February 23, 2013, Affymax and Takeda issued a press release indicating that they were recalling all batches of peginesatide from the market.<ref>FDA alerts health care providers of recall of anemia drug Omontys. U.S. Food and Drug Administration
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]]. On February 23, 2013, Affymax and Takeda issued a press release indicating that they were recalling all batches of peginesatide from the market.
[http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340899.htm]</ref>
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), or to darbepoetin for patients with chronic kidney disease who were not receiving dialysis (the PEARL study). However, the safety endpoint of cardiovascular events and death was worse for peginesatide than for darbepoetin in the PEARL study.  
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),<ref name="pmid23343061">{{cite journal | author = 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 | title = Peginesatide in patients with anemia undergoing hemodialysis | journal = N. Engl. J. Med. | volume = 368 | issue = 4 | pages = 307–19 |date=January 2013 | pmid = 23343061 | doi = 10.1056/NEJMoa1203165 }}</ref> or to darbepoetin for patients with chronic kidney disease who were not receiving dialysis (the PEARL study).<ref name="pmid23343062">{{cite journal | author = 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 | title = Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis | journal = N. Engl. J. Med. | volume = 368 | issue = 4 | pages = 320–32 |date=January 2013 | pmid = 23343062 | doi = 10.1056/NEJMoa1203166 }}</ref> However, the safety endpoint of cardiovascular events and death was worse for peginesatide than for darbepoetin in the PEARL study.  


==Medical uses==
==Medical uses==
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==Chemistry and mechanism of action==
==Chemistry and mechanism of action==
Peginesatide is a synthetic peptide, attached to [[polyethylene glycol]] ("[[PEGylated]]").<ref name="Stead" /> It mimics the structure of erythropoietin, the human glycoprotein which promotes red blood cell development.
Peginesatide is a synthetic peptide, attached to [[polyethylene glycol]] ("[[PEGylated]]"). It mimics the structure of erythropoietin, the human glycoprotein which promotes red blood cell development.


==Related drugs==
==Related drugs==
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 [[Hoffmann–La Roche|Roche]] in Europe, however United States patent law currently forbids their sale.<ref name="NYT" />
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 [[Hoffmann–La Roche|Roche]] in Europe, however United States patent law currently forbids their sale.
 
==References==
==References==
{{Reflist|2}}
{{Reflist|2}}


[[Category:Antianemic preparations]]
[[Category:Withdrawn drugs]]
[[Category:Withdrawn drugs]]
[[Category:Drug]]
[[Category:Drug]]

Revision as of 18:57, 9 April 2015

{{Drugbox | IUPAC_name = 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] | image = | width = | alt = | imagename =

| tradename = Omontys | Drugs.com = Omontys | MedlinePlus = | licence_EU = | licence_US = OMONTYS | DailyMedID = | pregnancy_AU = | pregnancy_US = C | pregnancy_category= | legal_AU = | legal_CA = | legal_UK = | legal_US = Rx-only | legal_status = | dependency_liability = | routes_of_administration = Subcutaneous, intravenous

| bioavailability = | protein_bound = | metabolism = | elimination_half-life = | excretion =

| CAS_number = 913976-27-9 | CAS_supplemental =
1185870-58-9 (acetate) | ATCvet = | ATC_prefix = B03 | ATC_suffix = XA04 | ATC_supplemental = | PubChemSubstance = 124490628 | IUPHAR_ligand = | DrugBank = | ChemSpiderID = NA | UNII = | KEGG = | ChEBI_Ref =  ☑Y | ChEBI = 66889 | ChEMBL = | synonyms =

| chemical_formula = C231H350N62O58S6[C2H4O]n | molecular_weight = 45 kDa | smiles = | StdInChI = | StdInChI_comment = | StdInChIKey = | density = | solubility = | specific_rotation = }}

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Overview

Peginesatide(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. On February 23, 2013, Affymax and Takeda issued a press release indicating that they were recalling all batches of peginesatide from the market. 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), or to darbepoetin for patients with chronic kidney disease who were not receiving dialysis (the PEARL study). 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"). It mimics the structure of erythropoietin, the human glycoprotein which promotes red blood cell development.

Related drugs

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.

References