AHFS/Drugs.com Monograph ATC code A16AB11 (WHO) | Routes of
administration Intravenous infusion Biological half-life 18.9-28.7 minutes | |
Trade names Elelyso / Uplyso (Latin America) Legal status In general: ℞ (Prescription only) | ||
Taliglucerase alfa, commercially known as Elelyso, is a biopharmaceutical drug developed by Protalix and Pfizer. The drug, a recombinant glucocerebrosidase used to treat Gaucher’s Disease, was the first plant-made pharmaceutical to win approval by the U.S. Food and Drug Administration. Each vial has 200 units of taliglucerase alfa.
Approval history
U.S. FDA New Drug Application (NDA) was granted approval in May 2012 for use in adults. U.S. FDA Supplemental New Drug Application (sNDA) for pediatric use was granted approved in August 2014. In Israel, the Israeli Ministry of Health granted approval in September 2012. 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 paediatric patients.
Taliglucerase alfa is made by the Israeli biotherapeutics company Protalix and sold by the American pharmaceutical company Pfizer