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  • Oxlumo receives orphan drug designation in Korea
  • by Eo, Yun-Ho | translator Alice Kang | Oct 21, 2024 05:48am
Drug for primary hyperoxaluria type 1
MFDS announces further announcements following the GIFT designation
Phase III study confirms a reduction in oxalate levels
The primary hyperoxaluria treatment Oxlumo received orphan drug designation in Korea.

The Ministry of Food and Drug Safety (MFDS) recently announced the designation through an orphan drug designation notice.

Oxlumo (lumasiran) was also recently designated a Global Innovative products on Fast Track (GIFT) by the MFDS.

The drug is an RNAi therapeutic for primary hyperoxaluria (PH1), a rare kidney disease that was approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2020.

RNAi is recognized as a next-generation gene therapy that has the advantage of providing specific access to disease-causing human genes.

PH1 is a rare disease caused by excessive production of
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