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 |
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| Pharmacokinetic data | |
| Elimination half-life | 18.9-28.7 minutes |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
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| Chemical and physical data | |
| Formula | C2580H3918N680O727S17 |
| Molar mass | 56638.78 g·mol−1 |
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.
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
References
- ^ Aviezer D, Brill-Almon E, Shaaltiel Y, Hashmueli S, Bartfeld D, Mizrachi S, et al. (2009). Ho PL (ed.). "A plant-derived recombinant human glucocerebrosidase enzyme--a preclinical and phase I investigation". PLOS ONE. 4 (3): e4792. Bibcode:2009PLoSO...4.4792A. doi:10.1371/journal.pone.0004792. PMC 2652073. PMID 19277123.
{{cite journal}}: CS1 maint: unflagged free DOI (link) - ^ Clinical trial number NCT00962260 for "Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease" at ClinicalTrials.gov
- ^ Kaiser J (April 2008). "Is the drought over for pharming?". Science. 320 (5875): 473–5. 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.
{{cite web}}: Unknown parameter|name-list-format=ignored (|name-list-style=suggested) (help) - ^ "Medical Pharmacy Trend Report" (PDF). Magellan Rx Management (seventh ed.). 2016. Archived from the original (PDF) on 29 March 2019.
- ^ Beitz, Julie. "Elenyso (taliglucerase alfa) NDA Approval" (PDF). Center for Drug Evaluation and Research. U.S. Food and Drug Administration.
{{cite web}}: Unknown parameter|name-list-format=ignored (|name-list-style=suggested) (help) - ^ "Elenyso (taliglucerase alfa): Highlights of Prescribing Information" (PDF). U.S. Food and Drug Administration.
- ^ "Supplement Approval Fulfillment of Postmarketing Requirement" (PDF). U.S. Food and Drug Administration.
- ^ "מאגר התרופות (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.
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