Imiglucerase is a medication used in the treatment of Gaucher's disease.[2][3]
It is a recombinant DNA-produced analogue of the human enzyme β-glucocerebrosidase.
Cerezyme is a freeze-dried medicine containing imiglucerase, manufactured by Genzyme Corporation. It is given intravenously after reconstitution as a treatment for Type 1 and Type 3[4] Gaucher's disease. It is available in formulations containing 200 or 400 units per vial. The specific activity of highly purified human enzyme is 890,000 units/mg,[5] meanwhile the enzyme activity produced by recombinant DNA technology is approximately 40 units/mg.[6] A typical dose is 2.5U/kg every two weeks, up to a maximum of 60 U/kg once every two weeks, and safety has been established from ages 2 and up.[7] It is one of more expensive medications, with an annual cost of $200,000 per person in the United States.[8] Imiglucerase has been granted orphan drug status in the United States, Australia, and Japan.[9]
Cerezyme was one of the drugs manufactured at Genzyme's Allston, Massachusetts plant, for which production was disrupted in 2009 after contamination with Vesivirus 2017.[10]
^"Cerezyme EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 18 January 2021.
^Weinreb NJ (August 2008). "Imiglucerase and its use for the treatment of Gaucher's disease". Expert Opinion on Pharmacotherapy. 9 (11): 1987–2000. doi:10.1517/14656566.9.11.1987. PMID 18627336. S2CID 72183308.
^Starzyk K, Richards S, Yee J, Smith SE, Kingma W (February 2007). "The long-term international safety experience of imiglucerase therapy for Gaucher disease". Molecular Genetics and Metabolism. 90 (2): 157–163. doi:10.1016/j.ymgme.2006.09.003. PMID 17079176.
^Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. 2018. Cerezyme 400 U-Pulver für ein Konzentrat zur Herstellung einer Infusionslösung.
^Pentchev PG, Brady RO, Blair HE, Britton DE, Sorrell SH (August 1978). "Gaucher disease: isolation and comparison of normal and mutant glucocerebrosidase from human spleen tissue". Proceedings of the National Academy of Sciences of the United States of America. 75 (8): 3970–3973. Bibcode:1978PNAS...75.3970P. doi:10.1073/pnas.75.8.3970. PMC 392911. PMID 29293.
^"Cerezyme Powder for concentrate for solution for infusion, Annex I: Summary of Product Characteristics" (PDF). Sanofi-Aventis Latvia SIA. Retrieved 26 April 2022 – via Ec.europa.eu.
^"Cerezyme (imiglucerase for injection)" (PDF). Genzyme product data sheet. Archived from the original (PDF) on 2003-06-05.
^Engelberg AB, Kesselheim AS, Avorn J (November 2009). "Balancing innovation, access, and profits--market exclusivity for biologics". The New England Journal of Medicine. 361 (20): 1917–1919. doi:10.1056/NEJMp0908496. PMID 19828525.
^"Imiglucerase". Orphanet. Retrieved 26 April 2022.
^Ailworth E, Weisman R (June 17, 2009). "Virus shuts Genzyme plant, holds up drugs for 8,000". The Boston Globe.
Imiglucerase is a medication used in the treatment of Gaucher's disease. It is a recombinant DNA-produced analogue of the human enzyme β-glucocerebrosidase...
and expensive procedure. A new version of Ceredase, called Cerezyme, Imiglucerase which Genzyme produced in 1994 using genetically modified cells in vitro...
Agalsidase beta IV Fabry disease Agalsidase alfa IV Gaucher disease Imiglucerase IV Gaucher disease Taliglucerase alfa IV Gaucher disease Velaglucerase...
harvesting, and are less expensive to manufacture (see imiglucerase). Deegan PB, Cox TM (2012). "Imiglucerase in the treatment of Gaucher disease: a history and...
not being fully committed to developing a drug that would compete with imiglucerase (brand name Cerezyme), Genzyme's flagship treatment for Gaucher's disease...
synthesis of most glycosphingolipids. Earlier treatments on the market (imiglucerase (approved in 1995), velaglucerase (approved in 2010), taliglucerase alfa...
C2532H3854N672O711S16 (molar mass: 55597.4 g/mol) may refer to: Alglucerase Imiglucerase This set index page lists chemical structure articles associated with...
retrieved July 9, 2015 "Imiglucerase on Orpha.net: The portal for rare diseases and orphan drugs". Weinreb NJ (August 2008). "Imiglucerase and its use for the...
patents in Amicus' patent portfolio on afegostat expired in 2015.: 12 Imiglucerase, a recombinant human β-glucocerebrosidase for enzyme replacement therapy...
malignancies - ASCO 2010; Abstract 8147; Improvement of bone disease by imiglucerase (Cerezyme) therapy in patients with skeletal manifestations of type 1...