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Cuprior
Published
Product name
Cuprior
Active ingredient
Trientine tetrahydrochloride
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Cuprior (trientine tetrahydrochloride) was approved for the following therapeutic use:
Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.
How this medicine works
Trientine is a copper-chelating agent whose principal mechanism of action is to eliminate absorbed copper from the body by forming a stable complex that is then eliminated through urinary excretion. Trientine may also chelate copper in the intestinal tract and so inhibit copper absorption.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Cuprior was considered favourable for the therapeutic use approved.
Sponsor