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  • Rare RCC drug Welireg may be commercialized in Korea this yr
  • by Eo, Yun-Ho | translator Alice Kang | Jan 6, 2023 05:57am
a new rare disease drug for renal cell carcinoma
Approved in 2021 after designation as an orphan drug in the US... is under MFDS review
Was designated as an orphan drug for von Hippel-Lindau disease in January last year
The new rare anticancer drug ¡®Welireg¡¯ is expected to be commercialized in Korea within the year.

According to industry sources, the Ministry of Food and Drug Safety is currently reviewing approval of MSD Korea¡¯s oral hypoxia-inducible factor-2 alpha (HIF-2¥á) inhibitor, ¡®Welireg (belzutifan).¡¯

The drug had been designated as an orphan drug in January last year for the treatment of Von Hippel-Lindau disease, and the company applied to receive approval for the indication the same year. In the US, the drug was granted priority review in 2021 and approved.

The indication the company applied for in Korea is also for the treatment of adult patients with VHL disease who require therapy for associated renal ce
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