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Oxlumo receives orphan drug designation in Korea

By Eo, Yun-Ho | translator Alice Kang

24.10.21 05:06:54

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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.

Eo, Yun-Ho(unkindfish@dailypharm.com)
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