Orphalan’s Cuvrior Receives the US FDA’s Approval for the Treatment of Adult Patients with Stable Wilson’s Disease
Shots:
- The US FDA has approved Cuvrior for the treatment of adult patients with stable WD who are de-coppered & tolerant to penicillamine
- The approval was based on data on the P-III (CHELATE) study to evaluate Cuvrior vs penicillamine in 53 adults with WD. The trial met its primary efficacy EPs i.e., Cuvrior was found to be non-inferior to penicillamine & showed that patients treated with Cuvrior had a similar mean NCC level to penicillamine @36wks., Cuvrior treated patients had a lower mean 24hr. urine copper excretion than penicillamine
- Cuvrior is a functionally scored tablet that contains 300mg trientine tetrahydrochloride. The product is expected to be available in early 2023
Ref: Orphalan | Image: Orphalan
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