Taliglucerase alfa

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.

Taliglucerase alfa

Clinical data
Trade names	Elelyso, others
AHFS/Drugs.com	Monograph
Pregnancy category	AU: B1
Routes of administration	Intravenous infusion
ATC code	A16AB11 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[1] US: ℞-only[2] In general: ℞ (Prescription only)
Pharmacokinetic data
Elimination half-life	18.9-28.7 minutes
Identifiers
CAS Number	37228-64-1
DrugBank	DB08876
ChemSpider	none
UNII	0R4NLX88O4
KEGG	D09675
ChEMBL	ChEMBL1964120
Chemical and physical data
Formula	C2580H3918N680O727S17
Molar mass	56638.78 g·mol−1

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]