Taliglucerase alfa
Pharmaceutical drug
From Wikipedia, the free encyclopedia
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.
category
- AU: B1
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| Trade names | Elelyso, others |
| AHFS/Drugs.com | Monograph |
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| Routes of administration | Intravenous infusion |
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| Pharmacokinetic data | |
| Elimination half-life | 18.9-28.7 minutes |
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| Chemical and physical data | |
| Formula | C2580H3918N680O727S17 |
| Molar mass | 56638.78 g·mol−1 |
Approval history
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
Economics
For 2016, Elelyso was ranked third for pharmaceuticals with the highest cost-per-patient, with an average cost of $483,242 per year.[11]
