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Peginesatide

Pharmaceutical drug

Summary

Pharmaceutical drug

| Drugs.com = | elimination_half-life = (acetate) 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.FDA alerts health care providers of recall of anemia drug Omontys. U.S. Food and Drug Administration https://web.archive.org/web/20130227025228/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340899.htm 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 (NDA)https://www.takeda.com/news/2014/20140616_6605.html

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.

References

References

  1. (January 2013). "Peginesatide in patients with anemia undergoing hemodialysis". N. Engl. J. Med..
  2. (January 2013). "Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis". N. Engl. J. Med..
  3. [http://www.ama-assn.org/resources/doc/usan/peginesatide.pdf Statement On A Nonproprietary Name Adopted By The USAN Council: Peginesatide]
  4. "Affymax, Inc Homepage".
  5. "Omontys (peginesatide): Official site for US physicians". [[Affymax]] and [[Takeda Pharmaceutical Company.
  6. Yao S. (March 27, 2012). "FDA approves Omontys to treat anemia in adult patients on dialysis". [[Food and Drug Administration.
  7. (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.
  8. (February 29, 2008). "Judge blocks anemia drug sales by Amgen Rival". New York Times.
Wikipedia Source

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