Immedica submits New Drug Submission (NDS) for Loargys® (pegzilarginase) to Health Canada
Stockholm, Sweden, October 31, 2025 – Immedica today announced that the submitted New Drug Submission (NDS) for Loargys® (pegzilarginase) to Health Canada has been accepted for review. This milestone marks the company’s first regulatory filing in Canada, highlighting Immedica’s continued expansion and commitment to addressing rare diseases on a global scale.
The pegzilarginase NDS has been granted priority review by Health Canada, reflecting the therapy’s potential to address a significant unmet medical need.
"The submission of pegzilarginase to Health Canada represents an important step in our mission to bring transformative therapies to patients with rare diseases worldwide," said Anders Edvell, CEO of Immedica. "This achievement reflects the dedication and expertise of our team, and we look forward to collaborating with Health Canada throughout the review process."
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. It is the first and only disease-modifying treatment.
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 HR & Communication
[email protected]
