Voranigo

Opinion

EMA has issued an opinion on this medicine

vorasidenib

Overview

On 24 July 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Voranigo¹, intended for the treatment of low grade astrocytoma or oligodendroglioma with an isocitrate dehydrogenase‑1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172 mutation in adults and adolescents from 12 years of age weighing at least 40 kg. The applicant for this medicinal product is Les Laboratoires Servier.

Voranigo will be available as 10 mg and 40 mg film-coated tablets. The active substance of Voranigo is vorasidenib, an antineoplastic agent (ATC code: L01XM04). Vorasidenib is an inhibitor that targets the mutant IDH1 and IDH2 enzymes. In patients with astrocytoma or oligodendroglioma, IDH1 and IDH2 mutations lead to overproduction of the oncogenic metabolite 2-hydroxyglutarate (2-HG), which results in impaired cellular differentiation contributing to oncogenesis. By inhibiting the IDH1 and IDH2 mutated proteins, vorasidenib inhibits the abnormal production of 2-HG thereby leading to differentiation of malignant cells and a reduction in their proliferation.

The benefit of Voranigo is prolonged radiographic progression-free survival in adults and adolescents with oligodendroglioma or astrocytoma with an IDH1 or IDH2 mutation compared with placebo, as shown in a phase 3 randomised, double-blind, placebo-controlled clinical study. The most common side effects with Voranigo include increased liver enzymes (ALT, AST, GGT), fatigue and diarrhoea.

The full indication is:

Voranigo as monotherapy is indicated for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1).

Treatment with Voranigo should be initiated and supervised by physicians experienced in the use of cancer medicinal products.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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¹ This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

CHMP summary of positive opinion for Voranigo

AdoptedReference Number: EMA/CHMP/227935/2025

Product details

• Name of medicine:
  Voranigo
• Active substance:
  vorasidenib hemicitrate hemihydrate
• International non-proprietary name (INN) or common name:
  vorasidenib
• Therapeutic area (MeSH):
  • Oligodendroglioma
  • Astrocytoma
• Anatomical therapeutic chemical (ATC) code:
  L01XX
• EMA product number:
  EMEA/H/C/006284
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation applicant:
  Les Laboratoires Servier
• Opinion adopted:
  24/07/2025
• Opinion status:
  Positive