Oxlumo receives orphan drug designation in Korea
By Eo, Yun-Ho | translator Alice Kang
24.10.21 05:06:54
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MFDS announces further announcements following the GIFT designation
Phase III study confirms a reduction in oxalate levels
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.
Eo, Yun-Ho(unkindfish@dailypharm.com)
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