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.
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Trade names | Elelyso / Uplyso (Latin America) |
AHFS/Drugs.com | Monograph |
Routes of administration | Intravenous infusion |
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Pharmacokinetic data | |
Elimination half-life | 18.9-28.7 minutes |
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Formula | C2580H3918N680O727S17 |
Molar mass | 56637.9397 g/mol g¡molâ1 |
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
- 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 EnzymeâA Preclinical and Phase I Investigation". PLoS ONE. 4 (3): e4792. doi:10.1371/journal.pone.0004792. PMC 2652073. PMID 19277123.
- "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?". Science. 320 (5875): 473â475. doi:10.1126/science.320.5875.473. PMID 18436771.
- Maxmen, Amy (2 may 2012) First plant-made drug on the market Nature, Biology & Biotechnology, Industry, Retrieved 26 June 2012
- https://www1.magellanrx.com/media/604882/2016mrxtrendreport_final.pdf
- NDA Approval
- Highlights of Prescribing Information
- Supplement Approval Fulfillment of Postmarketing Requirement
- "×××ר ×תר×פ×ת (Drug details for ELELYSO)". Ministry of Health Israel.
- "Summary Basis of Decision (SBD): ELELYSO". Health Canada. 2014-08-01. Archived from the original on 2014-08-06.