EMA — authorised 17 September 2025
- Application: EMEA/H/C/006284
- Marketing authorisation holder: Les Laboratoires Servier
- Local brand name: Voranigo
- Indication: 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).
- Pathway: orphan
- Status: approved
The European Medicines Agency (EMA) granted marketing authorisation for Voranigo, a medicinal product developed by Les Laboratoires Servier, on 17 September 2025. Voranigo 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 who have undergone surgical intervention and do not require immediate radiotherapy or chemotherapy. This authorisation was granted under the orphan designation, which is reserved for medicines treating rare diseases.