Pegzilarginase FDA Approval Status
FDA Approved: No
Generic name: pegzilarginase
Company: Aeglea BioTherapeutics, Inc.
Treatment for: Arginase 1 Deficiency
Pegzilarginase is a novel, recombinant human arginase 1 enzyme replacement therapy in development for the treatment of Arginase 1 Deficiency (ARG1-D).
- Pegzilarginase works to enzymatically deplete the elevated levels of the amino acid arginine in people with Arginase 1 Deficiency, a rare debilitating and progressive disease characterized by the accumulation of arginine.
- Pegzilarginase has received multiple regulatory designations, including Rare Pediatric Disease, Breakthrough Therapy, Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) as well as Orphan Drug Designation from the European Medicines Agency. A Biologics License Application (BLA) was submitted to the FDA in April 2022.
Development timeline for pegzilarginase
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
