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  • Domestic approval application filed for 'Voranigo' in KOR
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Feb 27, 2025 05:57am
A new malignant brain tumor therapy after over 20 years
MFDS has initiated the review¡¦designated as an orphan drug last year
The efficacy of the drug was proven through the Phase 3 INDIGO study
 ¡ã Product photo of Voranigo
New drug 'Voranigo' for malignant brain tumors has entered domestic approval procedure.

According to the industry sources, Servier Korea has recently submitted approval application to the Ministry of Food and Drug Safety (MFDS) for Voranigo (vorasidenib).

In Sepetember last year, this drug was designated an orphan drug in South Korea.

Voranigo is indicated for the treatment of diffuse gliomas with an isocitrate dehydrogenase (IDH) mutation. Voranigo targets patients with low-grade gliomas who are vulnerable to IDH1 or IDH2 mutations.

This drug is a bispecific inhibitor of IDH1/2, developed by multinational pharmaceutical company Servier. It targets glioma (astrocytoma or oligodendroglioma), a type of brai
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