Taliglucerase alfa

From Wikipedia, the free encyclopedia
Jump to: navigation, search
Taliglucerase alfa
Clinical data
Trade names Elelyso / Uplyso (Latin America)
AHFS/Drugs.com monograph
Legal status
  • Prescription only
Routes Intravenous infusion
Pharmacokinetic data
Half-life 18.9-28.7 minutes
Identifiers
CAS number 37228-64-1
ATC code A16AB11
DrugBank DB08876
UNII 0R4NLX88O4
KEGG D09675
ChEMBL CHEMBL1964120
Chemical data
Formula C2580H3918N680O727S17 
Mol. mass 56637.9397 g/mol

Taliglucerase alfa, commercially known as Elelyso, is a biopharmaceutical drug developed by Protalix and Pfizer.[1][2] 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.[3][4]

Approval history[edit]

U.S. FDA New Drug Application (NDA) was granted approval in May 2012 for use in adults.[5][6] U.S. FDA Supplemental New Drug Application (sNDA) for pediatric use was granted approved in August 2014.[7] In Israel, the Israeli Ministry of Health granted approval in September 2012.[8] 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.[9]

See also[edit]

References[edit]