avalglucosidase alfa-ngpt

FDA Drug Profile — Nexviazyme

Drug Details

Generic Name
avalglucosidase alfa-ngpt
Brand Names
Nexviazyme
Application Number
BLA761194
Sponsor
Genzyme Corporation
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
AVALGLUCOSIDASE ALFA

Indications and Usage

1 INDICATIONS AND USAGE NEXVIAZYME is indicated for the treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). NEXVIAZYME is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). ( 1 )