Taliglucerase alfa

Taliglucerase alfa
Clinical data
Trade names Elelyso / Uplyso (Latin America)
AHFS/Drugs.com monograph
  • ℞ (Prescription only)
Intravenous infusion
Pharmacokinetic data
Half-life 18.9-28.7 minutes
Identifiers
37228-64-1
A16AB11
DrugBank DB08876
UNII 0R4NLX88O4
KEGG D09675
ChEMBL CHEMBL1964120
Chemical data
Formula C2580H3918N680O727S17
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]

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]

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. doi:10.1371/journal.pone.0004792. PMC 2652073. PMID 19277123.
  2. ↑ http://clinicaltrials.gov/ct2/show/NCT00962260
  3. ↑ http://www.sciencemag.org/content/320/5875/473.summary
  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. ↑ http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_elelyso_140854-eng.php