Taliglucerase alfa
| Clinical data | |
|---|---|
| Trade names | Elelyso, others |
| AHFS/Drugs.com | Monograph |
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| Routes of administration | Intravenous infusion |
| ATC code | |
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| Pharmacokinetic data | |
| Elimination half-life | 18.9-28.7 minutes |
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| UNII | |
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| E number | {{#property:P628}} |
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| ECHA InfoCard | {{#property:P2566}}Lua error in Module:EditAtWikidata at line 29: attempt to index field 'wikibase' (a nil value). |
| Chemical and physical data | |
| Formula | C2580H3918N680O727S17 |
| Molar mass | 56638.78 g·mol−1 |
Taliglucerase alfa, sold under the brand name Elelyso among others, is a biopharmaceutical medication developed by Protalix and Pfizer.[3][4][full citation needed] The drug, a recombinant glucocerebrosidase used to treat Gaucher's disease, is the first plant-made pharmaceutical to win approval by the U.S. Food and Drug Administration (FDA).[5][6] Each vial has 200 units of taliglucerase alfa.
Approval history
[edit | edit source]The US FDA New Drug Application (NDA) was granted approval in May 2012, for use in adults.[7][2] The US 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 pediatric patients.[10]
Taliglucerase alfa is made by the Israeli biotherapeutics company Protalix and sold by the American pharmaceutical company Pfizer.[citation needed]
Society and culture
[edit | edit source]Economics
[edit | edit source]For 2016, Elelyso was ranked third for pharmaceuticals with the highest cost-per-patient, with an average cost of $483,242 per year.[11]
References
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- ^ Clinical trial number NCT00962260 for "Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease" at ClinicalTrials.gov
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