pegunigalsidase alfa

FDA Drug Profile — ELFABRIO

Drug Details

Generic Name
pegunigalsidase alfa
Brand Names
ELFABRIO
Application Number
BLA761161
Sponsor
Chiesi USA, Inc.
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients
PEGUNIGALSIDASE ALFA

Indications and Usage

1 INDICATIONS AND USAGE ELFABRIO is indicated for the treatment of adults with confirmed Fabry disease. ELFABRIO is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adults with confirmed Fabry disease. ( 1 )