Taliglucerase alfa
| Clinical data | |
|---|---|
| Trade names | Elelyso, Uplyso (Latin America) |
| AHFS/Drugs.com | Monograph |
| Pregnancy category |
|
| Routes of administration | Intravenous infusion |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Elimination half-life | 18.9-28.7 minutes |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| ChEMBL | |
| 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
Protalix and Pfizer.[2][3][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).[4][5]
Each vial has 200 units of taliglucerase alfa.
Approval history
The U.S. FDA New Drug Application (NDA) was granted approval in May 2012, for use in adults.[6][7] The 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 pediatric patients.[10]
Taliglucerase alfa is made by the Israeli
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]
References
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
- PMID 19277123.
- ^ Clinical trial number NCT00962260 for "Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease" at ClinicalTrials.gov
- S2CID 28407422.
- ^ Maxmen A (2 May 2012). "First plant-made drug on the market". Nature, Biology & Biotechnology, Industry. Archived from the original on 18 October 2012. Retrieved 26 June 2012.
- ^ Beitz J. "Elenyso (taliglucerase alfa) NDA Approval" (PDF). Center for Drug Evaluation and Research. U.S. Food and Drug Administration.
- ^ "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. Archived from the original on 2017-09-08. Retrieved 2017-09-08.
- ^ "Summary Basis of Decision (SBD): Elelyso". Health Canada. 2014-08-01. Archived from the original on 2014-08-06.
- ^ "Medical Pharmacy Trend Report" (PDF). Magellan Rx Management (seventh ed.). 2016. Archived from the original (PDF) on 29 March 2019.
External links
- "Taliglucerase alfa". Drug Information Portal. U.S. National Library of Medicine.
