Peginesatide
(
INN
Inns are generally establishments or buildings where travelers can seek lodging, and usually, food and drink. Inns are typically located in the country or along a highway; before the advent of motorized transportation they also provided accommo ...
/
USAN
280px, "Samguk Sagi" Book 04. Silla's Records. In 512, Usan-guk（于山國）was Ulleungdo（鬱陵島）
Usan-guk, or the State of Usan, occupied Ulleung-do and the adjacent islands during the Korean Three Kingdoms period. According to th ...
, trade name Omontys, formerly Hematide), developed by
Affymax and
, is an
erythropoietic agent, a
functional analog of
erythropoietin.
It was approved by the U.S. Food and Drug Administration for treatment of
anemia
Anemia or anaemia (British English) is a blood disorder in which the blood has a reduced ability to carry oxygen due to a lower than normal number of red blood cells, or a reduction in the amount of hemoglobin. When anemia comes on slowly, t ...
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.][Affymax and Takeda Announce Termination of Omontys® (peginesatide)
Product Collaboration and License Agreement. Takeda will withdraw the Omontys U.S. New Drug Application (ND]
/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),
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
Polyethylene glycol (PEG; ) is a polyether compound derived from petroleum with many applications, from industrial manufacturing to medicine. PEG is also known as polyethylene oxide (PEO) or polyoxyethylene (POE), depending on its molecular we ...
("PEGylated
PEGylation (or pegylation) is the process of both covalent and non-covalent attachment or amalgamation of polyethylene glycol (PEG, in pharmacy called macrogol) polymer chains to molecules and macrostructures, such as a drug, therapeutic protein ...
").
Related drugs
The erythropoietin analogs currently used to treat anemia in the United States are epoetin alfa
Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. Authorised by the European Medicines Agency on 28 August 2007, it stimulates erythropoiesis (increasing red blood cell levels) and is used to t ...
(sold under the names Procrit and Epogen) and darbepoetin alfa
Darbepoetin alfa (INN) is a re-engineered form of erythropoietin containing 5 amino acid changes (N30, T32, V87, N88, T90) resulting in the creation of 2 new sites for N-linked carbohydrate addition. It has a 3-fold longer serum half-life compar ...
(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
F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX ...
in Europe, Chugai in Japan, and VFMCRP in the United States.
References
Further reading
* http://www.labnews.co.uk/features/london-2012-holding-back-the-hematide/
{{Cytokine receptor modulators
Antianemic preparations
Withdrawn drugs
Drugs developed by Takeda Pharmaceutical Company
World Anti-Doping Agency prohibited substances