Taliglucerase alfa

Taliglucerase alfa, commercially known as Elelyso, is a biopharmaceutical drug developed by Protalix and Pfizer.[1][2] The drug, a recombinant glucocerebrosidase used to treat Gaucher's disease, was the first plant-made pharmaceutical to win approval by the U.S. Food and Drug Administration.[3][4] Each vial has 200 units of taliglucerase alfa.

Taliglucerase alfa
Clinical data
Trade namesElelyso / Uplyso (Latin America)
AHFS/Drugs.comMonograph
Routes of
administration		Intravenous infusion
ATC code
Legal status
Legal status
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Elimination half-life18.9-28.7 minutes
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC2580H3918N680O727S17
Molar mass56637.9397 g/mol g¡mol−1

For 2016, Elelyso was ranked third for pharmaceuticals with the highest cost-per-patient, with an average cost of $483,242 per year.[5]

Approval history

U.S. FDA New Drug Application (NDA) was granted approval in May 2012 for use in adults.[6][7] U.S. FDA Supplemental New Drug Application (sNDA) for pediatric use was granted approved in August 2014.[8] In Israel, the Israeli Ministry of Health granted approval in September 2012.[9] In Brazil, the Brazilian Health Surveillance Agency (ANVISA) granted approval in March 2013. In Canada, Health Canada issued a Notice of Compliance in May 2014 for both adults and paediatric patients.[10]

Taliglucerase alfa is made by the Israeli biotherapeutics company Protalix and sold by the American pharmaceutical company Pfizer.

See also
  • List of Israeli inventions and discoveries

References
  1. Aviezer, D; Brill-Almon, E; Shaaltiel, Y; Hashmueli, S; Bartfeld, D; Mizrachi, S; Liberman, Y; Freeman, A; et al. (2009). Ho, Paulo Lee (ed.). "A Plant-Derived Recombinant Human Glucocerebrosidase Enzyme—A Preclinical and Phase I Investigation". PLoS ONE. 4 (3): e4792. doi:10.1371/journal.pone.0004792. PMC 2652073. PMID 19277123.
  2. "Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease - Full Text View - ClinicalTrials.gov".
  3. Kaiser, Jocelyn (25 April 2008). "Is the Drought Over for Pharming?". Science. 320 (5875): 473–475. doi:10.1126/science.320.5875.473. PMID 18436771.
  4. Maxmen, Amy (2 may 2012) First plant-made drug on the market Nature, Biology & Biotechnology, Industry, Retrieved 26 June 2012
  5. https://www1.magellanrx.com/media/604882/2016mrxtrendreport_final.pdf
  6. NDA Approval
  7. Highlights of Prescribing Information
  8. Supplement Approval Fulfillment of Postmarketing Requirement
  9. "מאגר התרופות (Drug details for ELELYSO)". Ministry of Health Israel.
  10. "Summary Basis of Decision (SBD): ELELYSO". Health Canada. 2014-08-01. Archived from the original on 2014-08-06.


This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.