Peginesatide (original) (raw)
Peginesatide (INN/USAN, trade name Omontys, formerly Hematide), developed by 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. 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.
| Property | Value |
|---|---|
| dbo:abstract | Le péginésatide est une molécule activatrice du récepteur à l'érythropoïétine et est utilisé pour lutter contre l'anémie au cours de l'insuffisance rénale chronique. La molécule n'est pas un dérivé de l'érythropoïétine et n'a pas d'homologie avec cette dernière. Elle se donne en une injection mensuelle, ce qui la distingue des autres érythropoïétines qui sont administrées à plus brefs intervalles. Elle est aussi efficace que les autres érythropoïétines dans l'insuffisance rénale chronique dialysée ou non. Elle a été retirée du marché par les laboratoires producteurs en février 2013, en raison de réactions d'hypersensibilité grave, de type anaphylactique, ayant entraîné 0,02 % de décès après la première injection[réf. nécessaire]. (fr) Peginesatide (INN/USAN, trade name Omontys, formerly Hematide), developed by 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. 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. 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. (en) |
| dbo:alternativeName | Omontys (en) |
| dbo:casNumber | (acetate) 913976-27-9 |
| dbo:chEBI | 66889 |
| dbo:chemicalFormula | C231H350N62O58S6[C2H4O]n |
| dbo:fdaUniiCode | JX56W9N61Q |
| dbo:kegg | D09946 |
| dbo:wikiPageExternalLink | http://www.labnews.co.uk/features/london-2012-holding-back-the-hematide/ |
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| dbo:wikiPageWikiLink | dbc:World_Anti-Doping_Agency_prohibited_substances dbr:Erythropoiesis dbr:Epoetin_alfa dbr:Anemia dbr:Subcutaneous_injection dbr:Functional_analog_(chemistry) dbc:Takeda_Pharmaceutical_Company_brands dbr:Mircera dbr:Acetate dbr:Darbepoetin_alfa dbr:Erythropoietin dbr:Chronic_kidney_disease dbc:Antianemic_preparations dbc:Withdrawn_drugs dbr:International_Nonproprietary_Name dbr:Kidney_dialysis dbr:Takeda_Pharmaceutical_Company dbr:Polyethylene_glycol dbr:Hoffmann–La_Roche dbr:United_States_Adopted_Name dbr:Intravenous dbr:Chugai dbr:PEGylated dbr:Affymax |
| dbp:atcPrefix | B03 (en) |
| dbp:atcSuffix | XA04 (en) |
| dbp:casNumber | 913976 (xsd:integer) |
| dbp:chebi | 66889 (xsd:integer) |
| dbp:chemicalFormula | C231H350N62O58S6[C2H4O]n (en) |
| dbp:chemspiderid | none (en) |
| dbp:iupacName | Poly, α-hydro-ω-methoxy-, diester with 21N6,21'N6-{[imino]bis}bis[N-acetylglycylglycyl-(L)-leucyl-(L)-tyrosyl-(L)-alanyl-(L)-cysteinyl-(L)-histidyl-(L)-methionylglycyl-(L)-prolyl-(L)-isoleucyl-(L)-threonyl-3--(L)-alanyl-(L)-valyl-(L)-cysteinyl-(L)-glutaminyl-(L)-prolyl-(L)-leucyl-(L)-arginyl-N-methylglycyl-(L)-lysinamide] cyclic ,-bis (en) |
| dbp:iupharLigand | 7447 (xsd:integer) |
| dbp:kegg | D09946 (en) |
| dbp:legalUs | Rx-only (en) |
| dbp:licenceUs | OMONTYS (en) |
| dbp:molecularWeight | 45 (xsd:integer) |
| dbp:pregnancyUs | C (en) |
| dbp:pubchemsubstance | 124490628 (xsd:integer) |
| dbp:routesOfAdministration | dbr:Subcutaneous_injection dbr:Intravenous |
| dbp:tradename | Omontys (en) |
| dbp:unii | JX56W9N61Q (en) |
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| gold:hypernym | dbr:Agent |
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| rdfs:comment | Peginesatide (INN/USAN, trade name Omontys, formerly Hematide), developed by 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. 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. (en) Le péginésatide est une molécule activatrice du récepteur à l'érythropoïétine et est utilisé pour lutter contre l'anémie au cours de l'insuffisance rénale chronique. La molécule n'est pas un dérivé de l'érythropoïétine et n'a pas d'homologie avec cette dernière. Elle se donne en une injection mensuelle, ce qui la distingue des autres érythropoïétines qui sont administrées à plus brefs intervalles. Elle est aussi efficace que les autres érythropoïétines dans l'insuffisance rénale chronique dialysée ou non. (fr) |
| rdfs:label | Péginésatide (fr) Peginesatide (en) |
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