Taliglucerase alfa
Clinical data | |
---|---|
Trade names | Elelyso / Uplyso (Latin America) |
AHFS/Drugs.com | Monograph |
Routes of administration | Intravenous infusion |
ATC code | A16AB11 (WHO) |
Legal status | |
Legal status |
|
Pharmacokinetic data | |
Biological half-life | 18.9-28.7 minutes |
Identifiers | |
CAS Number | 37228-64-1 |
DrugBank | DB08876 |
ChemSpider | none |
UNII | 0R4NLX88O4 |
KEGG | D09675 |
ChEMBL | CHEMBL1964120 |
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]
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
- ↑ 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.
- ↑ http://clinicaltrials.gov/ct2/show/NCT00962260
- ↑ http://www.sciencemag.org/content/320/5875/473.summary
- ↑ Maxmen, Amy (2 may 2012) First plant-made drug on the market Nature, Biology & Biotechnology, Industry, Retrieved 26 June 2012
- ↑ http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022458s000ltr.pdf
- ↑ http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022458lbl.pdf
- ↑ http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s003,022458Orig1s006ltr.pdf
- ↑ http://www.old.health.gov.il/units/pharmacy/trufot/PerutTrufa.asp?Reg_Number=148%2067%2033413%2000&safa=e
- ↑ http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_elelyso_140854-eng.php