Te Arai BioFarma are happy to announce that Medsafe has approved an innovative new treatment for Wilson's Disease, trientine tetrahydrochloride (Cuprior).
Wilson’s Disease is a rare inherited disorder of copper transport primarily affecting the liver and brain, affecting about 1 in every 30,000 people worldwide. For the last 70 years d- Penicillamine has been the only approved first-line treatment of Wilson’s Disease and to which about a third of patients develop intolerance. Cuprior is a copper chelating agent approved by Medsafe for patients who are intolerant to d-Penicillamine.
Cuprior has already been approved in Europe and Australia. Te Arai BioFarma is proud to partner with Orphalan, the developer and manufacturer of Cuprior, to make this treatment available to New Zealand patients. Orphalan identifies, develops and delivers worldwide innovative therapies for people living with Orphan diseases.
Cuprior is currently being evaluated by the FDA for the treatment of Wilson's Disease following positive data from the CHELATE Phase 3 clinical trial that met its primary efficacy endpoint by demonstrating that TETA 4HCl was non-inferior to d-Penicillamine as measured by copper speciation evaluation of non-ceruloplasmin copper (NCC).
"The registration of Cuprior trientine tetrahydrochloride is a continuation of Te Arai BioFarmas' commitment to the treatment of rare disorders and the supply of life saving medicines" Regulatory Director Julia Reese.
Cuprior is a store at room temperature scored tablet, allowing convenient and specific dosing for people with Wilsons Disease.
For full product details please visit medsafe.govt.nz