pegzilarginase-nbln
Drug Details
- Generic Name
- pegzilarginase-nbln
- Brand Names
- Loargys
- Application Number
- BLA761211
- Sponsor
- Immedica Pharma US Inc.
- NDC Codes
- 2
- Dosage Forms
- INJECTION
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Active Ingredients
- PEGZILARGINASE
Indications and Usage
1 INDICATIONS AND USAGE LOARGYS is indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. This indication is approved under accelerated approval based on reduction of plasma arginine [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. LOARGYS is an arginine specific enzyme indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. ( 1 ) This indication is approved under accelerated approval based on reduction of plasma arginine. ( 14 ) Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 1 )