Chemistry: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 |
| Identifiers | |
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| DrugBank | |
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| 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] 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
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]
References
- ↑ "Prescription medicines: registration of new chemical entities in Australia, 2014". 21 June 2022. https://www.tga.gov.au/resources/resource/guidance/prescription-medicines-registration-new-chemical-entities-australia-2014.
- ↑ 2.0 2.1 "Elelyso- taliglucerase alfa injection, powder, lyophilized, for solution". 18 July 2024. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa3cbd5d-677c-4b19-9032-d9182cb69a83.
- ↑ "A plant-derived recombinant human glucocerebrosidase enzyme--a preclinical and phase I investigation". PLOS ONE 4 (3). 2009. doi:10.1371/journal.pone.0004792. PMID 19277123. Bibcode: 2009PLoSO...4.4792A.
- ↑ Clinical trial number NCT00962260 for "Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease" at ClinicalTrials.gov
- ↑ "Is the drought over for pharming?". Science 320 (5875): 473–5. April 2008. 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. http://blogs.nature.com/news/2012/05/first-plant-made-drug-on-the-market.html.
- ↑ Beitz, Julie. "Elenyso (taliglucerase alfa) NDA Approval". Center for Drug Evaluation and Research. U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022458s000ltr.pdf.
- ↑ "Supplement Approval Fulfillment of Postmarketing Requirement". U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s003,022458Orig1s006ltr.pdf.
- ↑ "מאגר התרופות (Drug details for Elelyso)". Ministry of Health Israel. https://www.old.health.gov.il/units/pharmacy/trufot/PerutTrufa.asp?Reg_Number=148%2067%2033413%2000&safa=e.
- ↑ "Summary Basis of Decision (SBD): Elelyso". Health Canada. 2014-08-01. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_elelyso_140854-eng.php.
- ↑ "Medical Pharmacy Trend Report". Magellan Rx Management. 2016. https://www1.magellanrx.com/media/604882/2016mrxtrendreport_final.pdf.
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