Cuvrior FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 24, 2022.
FDA Approved: Yes (First approved April 28, 2022)
Brand name: Cuvrior
Generic name: trientine tetrahydrochloride
Dosage form: Tablets
Company: Orphalan SA
Treatment for: Wilson's Disease
Cuvrior (trientine tetrahydrochloride) is a copper chelator indicated for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine.
- Wilson’s Disease is a rare inherited disorder of copper transport that leads to excess copper accumulation. It primarily affects the liver and brain and can be fatal if left untreated.
- Cuvrior tablets are administered orally two times a day on an empty stomach.
- Warnings and precautions associated with Cuvrior include potential for worsening of clinical symptoms at initiation of therapy, copper deficiency, iron deficiency, and hypersensitivity reactions.
- Common adverse reactions include abdominal pain, change of bowel habits, rash, alopecia, and mood swings.
Development timeline for Cuvrior
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