Taliglucerase alfa

Taliglucerase alfa
Clinical data
Trade namesElelyso, others
AHFS/Drugs.comMonograph
Pregnancy
category
  • AU: B1
Routes of
administration		Intravenous infusion
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)[1]
  • US: ℞-only[2]
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Elimination half-life18.9-28.7 minutes
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC2580H3918N680O727S17
Molar mass56638.78 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

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. ^ a b "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.


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