|Trade names||Elelyso / Uplyso (Latin America)|
|Biological half-life||18.9-28.7 minutes|
|Chemical and physical data|
|Molar mass||56637.9397 g/mol|
Taliglucerase alfa, commercially known as Elelyso, is a biopharmaceutical drug developed by Protalix and Pfizer. 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. Each vial has 200 units of taliglucerase alfa.
U.S. FDA New Drug Application (NDA) was granted approval in May 2012 for use in adults. U.S. FDA Supplemental New Drug Application (sNDA) for pediatric use was granted approved in August 2014. In Israel, the Israeli Ministry of Health granted approval in September 2012. 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.
- 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 . PMID 19277123. doi:10.1371/journal.pone.0004792.
- "Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease - Full Text View - ClinicalTrials.gov".
- 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.
- Maxmen, Amy (2 may 2012) First plant-made drug on the market Nature, Biology & Biotechnology, Industry, Retrieved 26 June 2012
- "Summary Basis of Decision (SBD): ELELYSO". Health Canada. 2014-08-01. Archived from the original on 2014-08-06.
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