Pharmaceutical drug
Pharmaceutical compound
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.
^ "Prescription medicines: registration of new chemical entities in Australia, 2014" . Therapeutic Goods Administration (TGA) . 21 June 2022. Retrieved 10 April 2023 .
^ "Elelyso- taliglucerase alfa injection, powder, lyophilized, for solution" . DailyMed . 18 July 2024. Retrieved 26 October 2024 .
^ 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 .
^ Clinical trial number NCT00962260 for "Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease" at ClinicalTrials.gov
^ 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 .
^ 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 .