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MSD Welireg is about to be approved in Korea

By Lee, Hye-Kyung | translator Kim, Jung-Ju

23.04.18 05:50:35

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Application for permission in August of last year, safety and efficacy review completed by the Ministry of Food and Drug Safety



Domestic approval of Welireg, an oral hypoxia-inducible factor-2 alpha (HIF-2¥á) inhibitor, is imminent. According to the pharmaceutical industry on the 18th, the Ministry of Food and Drug Safety completed the safety and efficacy review of MSD Korea's Welireg.

This drug was approved in Korea in August of last year and was designated as an orphan drug for Von Hippel-Lindau indications in January of last year prior to MSD Korea's application for approval. Welireg obtained approval from the US FDA in August 2021 as an adult VHL treatment that does not require urgent surgery but requires the treatment of RCC, CNS hemangioblastoma, or pNET.

Welireg, approved in the United Kingdom and Canada, s

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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