Type of information: Granting of a Market Authorisation in the EU
Product name: Cuprior®
Compound: trientine tetrahydrochloride
Therapeutic area: Rare diseases - Metabolic diseases
- chelating copper agent. Trientine is a copper-chelating agentthat removes copper from the body by forming a stable complex that is then eliminated through urinary excretion. Trientine may also inhibit copper absorption from the intestinal tract.
- Cuprior® is a hybrid medicine of Trientine dihydrochloride 300 mg capsules (equivalent to 200 mg trientine base) which have been authorised in the EU since 8 August 1985. It works in the same way as the reference product but, unlike the reference product, the trientine salt in Cuprior® (tetrahydrochloride) does not require refrigerated storage.
Company: GMP Orphan (France) Voisin Consulting (France)
Disease: Wilson disease
- • On April 21, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Cuprior®, intended for the treatment of Wilson’s disease.
Cuprior® will be available as 150 mg tablets (trientine base).
The benefits with Cuprior® are its ability to decrease serum copper levels in patients with Wilson’s disease. Excessive levels of copper lead to neurological abnormalities and hepatic dysfunction. The most commonly reported adverse reaction with trientine is nausea. Serious iron deficiency anaemia and severe colitis may occur during treatment.
- • On March 3, 2016, the FDA has granted orphan drug designation for trientine tetrahydrochloride for treatment of Wilson’s disease.
- • On 10-12 February 2015 the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for trientine tetrahydrochloride for treatment of Wilson's disease.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
UE authorization: 2017-09-05
Favourable opinion UE: 2017-04-21
Favourable opinion USA:
Orphan status USA: 2016-03-03
Orphan status UE: 2015-03-19
Pediatric exclusivit _USA:
Pediatric exclusivity UE: