Voranigo (vorasidenib)
- Region
- 🇪🇺 EU
- Active substance
- vorasidenib
- Company
- Les Laboratoires Servier
- Status
- Authorised
- Therapeutic area
- Oligodendroglioma; Astrocytoma
- CHMP opinion
- Thu 24 Jul 2025
- EU approval
- Wed 17 Sep 2025
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/006284
- ATC
- L01XM04
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.