Treats hyperargininemia. BLA 761211, held by Immedica Pharma AB. Pegzilarginase-Nbln.
As of Nov 13, 2026, BLA 761211 (Loargys), held by Immedica Pharma AB, was first approved by FDA on Feb 23, 2026, with 0 approved supplements and 1 published complete response letter.
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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Aug 6, 2025 | BLA 761211 | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loargys0.1MG/KG · injectable; injection | Pegzilarginase-Nbln | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
