LOARGYS® (pegzilarginase for injection) approved in Canada for the treatment of Arginase 1 Deficiency (ARG1-D)

STOCKHOLM, Sweden, June 1, 2026 -  Immedica announces that Health Canada has granted a Notice of Compliance (NOC) on May 29, 2026 for LOARGYS® (pegzilarginase for injection) for the treatment of hyperargininemia in adults and pediatric patients aged 2 years and older with arginase 1 deficiency (ARG1-D), in conjunction with dietary protein restriction.

"Today’s approval marks a major milestone for Immedica, but an even greater one for people living with ARG1-D and their families in Canada. As the first and only disease-modifying treatment for ARG1-D, LOARGYS provides healthcare professionals with a treatment option specifically designed to address this ultra-rare disease, said Anders Edvell, CEO of Immedica

About ARG1-D 
ARG1-D is an ultra-rare, progressive and serious inherited metabolic disorder. The principal defect in ARG1-D leads to accumulation of plasma arginine (hyperargininemia) and its toxic metabolites. Patients are often diagnosed in late infancy or early childhood, and the symptoms include spasticity, seizures, developmental delay, intellectual disability, and early mortality. ARG1-D is one of the eight urea cycle disorder (UCD) subtypes. It shares some overlapping features with other UCDs, including impaired nitrogen excretion. However, in ARG1-D, hyperammonemia is generally less severe. 

About Loargys® (pegzilarginase) 
Pegzilarginase is a novel, recombinant, human arginase-1 enzyme that has been shown to rapidly and sustainably lower levels of the amino acid arginine and its toxic metabolites in plasma, making it the first and only therapy proven to lower plasma arginine. Loargys is approved in the EU, UK, US, Canda and Oman for the treatment of arginase 1 deficiency (ARG1-D), also known as hyperargininemia, in adults, adolescents, and children 2 years and older.

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, RARE endocrinology and specialty care. Immedica was founded in 2018 and employs today around 180 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 HR & Communication
[email protected]