Loargys® (pegzilarginase) granted marketing authorization in Oman for the treatment of arginase 1 deficiency (ARG1-D)
Stockholm, Sweden, December 10, 2025 – Immedica today announces that Loargys® (pegzilarginase) has been granted marketing authorization in Oman for the treatment of arginase 1 deficiency (ARG1-D), also known as hyperargininemia, in adults, adolescents and children aged 2 years and older.
ARG1-D is a rare, inherited metabolic disorder that can lead to the accumulation of arginine and associated toxic metabolites, with potentially serious, progressive and life-impacting consequences for patients and families.
“The approval in Oman is the first in the MENA region and supports Immedica’s ambition to broaden access to essential therapies for rare diseases in markets where unmet medical need remains high” said Ashraf Attia General Manager of Immedica in MENA.
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About Loargys®
Loargys (pegzilarginase) is a novel recombinant human enzyme and has been shown to rapidly and sustainably lower levels of the amino acid arginine and its toxic metabolites in plasma accompanied by improvements in clinical outcomes. Loargys is approved in the EU, UK and Oman for the treatment of ARG1-D, also known as hyperargininemia, in adults, adolescents and children aged 2 years and older. It is the first and only disease-modifying treatment for ARG1-D.
About ARG1-D
ARG1-D is one of the eight urea cycle disorder (UCD) subtypes. It shares overlapping features with other UCDs and the most prominent is the impairment in excreting nitrogen. However, in ARG1-D, hyperammonemia is generally less severe and instead these patients show spasticity, which other subtypes do not. The principal defect in ARG1-D leads to accumulation of plasma arginine and its toxic metabolites, which occurs in almost all patients with this disorder. Patients are often diagnosed in late infancy or early childhood and the symptoms include spasticity, seizures, developmental delay, intellectual disability, and early mortality.
About Immedica
Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care products. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory, medical affairs and market access, as well as a global distribution network serving patients in more than 50 countries. Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica’s therapeutic areas are within RARE metabolic, RARE hematology & oncology, RARE neurology and specialty care. Immedica was founded in 2018 and employs today around 150 people across Europe, the Middle East and the United States. Immedica is backed by the investment firms KKR and Impilo.
For more information visit www.immedica.com.
Immedica contact:
Linda Holmström
VP, Head of Communication
[email protected]
