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  • New RNAi drug 'Rivfloza' gets ODD in KOR
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Jun 16, 2025 06:04am
Treatment option for primary hyperoxaluria¡¦obtained the U.S. approval in 2023
Demonstrated to lower urinary oxalate (Uox) excretion rate through the PHYOXTM2 study
The rare genetic disorder treatment 'Rivfloza' has been designated as an orphan drug in South Korea.

The Ministry of Food and Drug Safety recently announced this on its notification board. Rivfloza (nedosiran) is indicated to treat children over 9 years of age and above and adults with 'primary hyperoxaluria type 1 (PH1)' and relatively preserved kidney function.

Rivfloza was approved by the U.S. Food and Drug Administration (FDA) in October 2023. It is the first RNAi-based rug developed using Novo Nordisk's GalXC RNAi technology platform.

The efficacy of Rivfloza was demonstrated through the results obtained from the Phase 2 PHYOXTM 2 study and the interim analysis data from the Phase 3 PHYOXTM 3 extension
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