Taliglucerase alfa

Taliglucerase alfa
Clinical data
Trade names Elelyso / Uplyso (Latin America)
AHFS/Drugs.com Monograph
Routes of
administration		 Intravenous infusion
ATC code
Legal status
Legal status
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Biological half-life 18.9-28.7 minutes
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
Formula C2580H3918N680O727S17
Molar mass 56637.9397 g/mol

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.

Approval history

U.S. FDA New Drug Application (NDA) was granted approval in May 2012 for use in adults.[5][6] U.S. FDA Supplemental New Drug Application (sNDA) for pediatric use was granted approved in August 2014.[7] In Israel, the Israeli Ministry of Health granted approval in September 2012.[8] 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.[9]

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

See also

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. PMC 2652073 Freely accessible. PMID 19277123. doi:10.1371/journal.pone.0004792.
  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?". 320 (5875): 473–475. PMID 18436771. doi:10.1126/science.320.5875.473 – via www.sciencemag.org.
  4. ↑ Maxmen, Amy (2 may 2012) First plant-made drug on the market Nature, Biology & Biotechnology, Industry, Retrieved 26 June 2012
  5. ↑ http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022458s000ltr.pdf
  6. ↑ http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022458lbl.pdf
  7. ↑ http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s003,022458Orig1s006ltr.pdf
  8. ↑ http://www.old.health.gov.il/units/pharmacy/trufot/PerutTrufa.asp?Reg_Number=148%2067%2033413%2000&safa=e
  9. ↑ "Summary Basis of Decision (SBD): ELELYSO". Health Canada. 2014-08-01. Archived from the original on 2014-08-06.
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