CANbridge’ CAN108 (Livmarli) Receives TFDA Approval for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome in Taiwan
Shots:
- TFDA has approved CAN108 (Livmarli), a minimally absorbed ileal bile acid transporter inhibitor for cholestatic pruritus in patients with ALGS aged ≥1yr. The approval was based on the (ICONIC) study & (RISE) infant safety study as well as data from the program in patients with ALGS
- The (ICONIC) study showed a significant & clinical reduction in pruritus over PBO and reductions in serum bile acids which were durably maintained over several years of treatment. Interim data from the (RISE) study supports the indication in the infant group at the age of ≤12mos.
- Livmarli is being studied in late-stage clinical studies in other rare cholestatic liver diseases. The therapy received BTD for ALGS & PFIC type 2; ODD for ALGS, PFIC, and BA from the US FDA
Ref: PR Newswire | Image: Canbridge
Related News:- Mirum’s Livmarli Receives Health Canada Authorization for Cholestatic Pruritus in Patients with Alagille Syndrome
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