Servier wins EU nod for Voranigo in IDH-mutant glioma
French drugmaker Servier has secured European Commission clearance for Voranigo (vorasidenib) as the first targeted therapy for Grade 2 IDH-mutant glioma. The approval covers adults and adolescents from age 12 who have undergone surgery but do not yet need radiotherapy or chemotherapy.
The decision follows a positive opinion from the European Medicines Agency's (EMA) CHMP in July and is supported by Phase III INDIGO trial data published in The New England Journal of Medicine. Voranigo significantly prolonged progression-free survival versus placebo and demonstrated a manageable safety profile. The authorization extends across all 27 EU member states plus Iceland, Liechtenstein and Norway.
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