Taliglucerase alfa explained

Taliglucerase alfa, sold under the brand name Elelyso among others, is a biopharmaceutical medication developed by Protalix and Pfizer.[1] 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).[2] [3] 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.[4] [5] The U.S. FDA Supplemental New Drug Application (sNDA) for pediatric use was granted approved in August 2014.[6] In Israel, the Israeli Ministry of Health granted approval in September 2012.[7] 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.[8]

Taliglucerase alfa is made by the Israeli biotherapeutics company Protalix and sold by the American pharmaceutical company Pfizer.

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.[9]

External links

Notes and References

  1. Aviezer D, Brill-Almon E, Shaaltiel Y, Hashmueli S, Bartfeld D, Mizrachi S, Liberman Y, Freeman A, Zimran A, Galun E . 6 . A plant-derived recombinant human glucocerebrosidase enzyme--a preclinical and phase I investigation . PLOS ONE . 4 . 3 . e4792 . 2009 . 19277123 . 2652073 . 10.1371/journal.pone.0004792 . 2009PLoSO...4.4792A . Ho PL . free .
  2. Kaiser J . Is the drought over for pharming? . Science . 320 . 5875 . 473–5 . April 2008 . 18436771 . 10.1126/science.320.5875.473 . 28407422 .
  3. Web site: Maxmen . Amy . vanc . 2 May 2012 . First plant-made drug on the market . Nature, Biology & Biotechnology, Industry . 26 June 2012 . 18 October 2012 . https://web.archive.org/web/20121018222214/http://blogs.nature.com/news/2012/05/first-plant-made-drug-on-the-market.html . dead .
  4. Web site: Julie . Beitz . vanc . Elenyso (taliglucerase alfa) NDA Approval . Center for Drug Evaluation and Research . U.S. Food and Drug Administration .
  5. Web site: Elenyso (taliglucerase alfa): Highlights of Prescribing Information . U.S. Food and Drug Administration .
  6. Web site: Supplement Approval Fulfillment of Postmarketing Requirement . U.S. Food and Drug Administration .
  7. Web site: מאגר התרופות (Drug details for Elelyso) . Ministry of Health Israel . 2017-09-08 . 2017-09-08 . https://web.archive.org/web/20170908112755/https://www.old.health.gov.il/units/pharmacy/trufot/PerutTrufa.asp?Reg_Number=148%2067%2033413%2000&safa=e . dead .
  8. Web site: Summary Basis of Decision (SBD): Elelyso . Health Canada . 2014-08-01 . https://web.archive.org/web/20140806003328/http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_elelyso_140854-eng.php . 2014-08-06.
  9. Web site: Magellan Rx Management . Medical Pharmacy Trend Report . 2016 . seventh . https://web.archive.org/web/20190329161935/https://www1.magellanrx.com/media/604882/2016mrxtrendreport_final.pdf . 29 March 2019 .

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