Taliglucerase alfa

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.

Taliglucerase alfa

Clinical data
Trade names	Elelyso, others
AHFS/Drugs.com	Monograph
Pregnancy category	AU: B1
Routes of administration	Intravenous infusion
ATC code	A16AB11 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[1] US: ℞-only[2] In general: ℞ (Prescription only)
Pharmacokinetic data
Elimination half-life	18.9-28.7 minutes
Identifiers
CAS Number	37228-64-1
DrugBank	DB08876
ChemSpider	none
UNII	0R4NLX88O4
KEGG	D09675
ChEMBL	ChEMBL1964120
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]

References

1. "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
2. "Elelyso- taliglucerase alfa injection, powder, lyophilized, for solution". DailyMed. 18 July 2024. Retrieved 26 October 2024.
3. 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.
4. Clinical trial number NCT00962260 for "Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease" at ClinicalTrials.gov
5. Kaiser J (April 2008). "Is the drought over for pharming?". Science. 320 (5875): 473–5. doi:10.1126/science.320.5875.473. PMID 18436771. S2CID 28407422.
6. 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.
7. Beitz J. "Elenyso (taliglucerase alfa) NDA Approval" (PDF). Center for Drug Evaluation and Research. U.S. Food and Drug Administration.
8. "Supplement Approval Fulfillment of Postmarketing Requirement" (PDF). U.S. Food and Drug Administration.
9. "מאגר התרופות (Drug details for Elelyso)". Ministry of Health Israel. Archived from the original on 2017-09-08. Retrieved 2017-09-08.
10. "Summary Basis of Decision (SBD): Elelyso". Health Canada. 2014-08-01. Archived from the original on 2014-08-06.
11. "Medical Pharmacy Trend Report" (PDF). Magellan Rx Management (seventh ed.). 2016. Archived from the original (PDF) on 29 March 2019.