← All approvals · Rare & genetic · 2026
Loargys (pegzilarginase-nbln)
The FDA approved Loargys (pegzilarginase-nbln) on February 23, 2026 to treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction.
- Brand name
- Loargys
- Generic name
- pegzilarginase-nbln
- FDA approval date
- February 23, 2026
- Approved use (FDA wording)
- To treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction
- Company
- Immedica Pharma Ab
- Application
- BLA761211
- Dosage form / route
- Injectable · Injection
- Boxed warning on label
- Yes (see the FDA label)
- Category on this site
- Rare & genetic
Indications and usage, from the FDA label
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 ) T…