Loargys (pegzilarginase)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pegzilarginase
- Company
- Immedica Pharma AB
- Status
- Authorised
- Therapeutic area
- Hyperargininemia
- CHMP opinion
- Thu 12 Oct 2023
- EU approval
- Fri 15 Dec 2023
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005484
- ATC
- A16AB24
- Official record
- www.ema.europa.eu
Indication
Loargys is indicated for the treatment of arginase 1 deficiency (ARG1 D), also known as hyperargininemia, in adults, adolescents and children aged 2 years and older.
Regulatory milestones
Mon 23 Feb 2026🇺🇸 FDA approval
FDA approves Loargys (pegzilarginase-nbln), a new medicine
Immedica Pharma Ab; BLA761211; New biologic, Priority review; injectable · source
Same substance in other markets
- 🇺🇸 Loargys Approved · Immedica Pharma Ab
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.