Cuprior
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.
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.
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.