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May 2, 2022May 2, 2022 – The U.S. FDA has approved CuvriorTM (trientine tetrahydrochloride) to treat stable Wilson’s disease in adults who are de-coppered and tolerant to penicillamine, an FDA-approved first-line treatment for the disease.
- Wilson’s disease is a rare, genetic disorder in which the body cannot properly filter out copper. The excess copper that remains is stored in various bodily tissues, including the eyes, liver, and brain. De-coppering is the process of using chelating agents to help remove copper from the body.
- Cuvrior is taken by mouth on an empty stomach twice per day. The total daily dose can range from 300mg to 3,000mg, with dosing adjusted according to clinical assessment and laboratory monitoring of copper.
- Orphalan, the manufacturer, plans to launch Cuvrior in early 2023.