EMA — authorised 20 April 2026
- Application: EMEA/H/C/006140
- Marketing authorisation holder: Ipsen Pharma
- Local brand name: Ojemda
- Indication: Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (for biomarkers-based patient selection, see section 4.2)
- Pathway: conditional, orphan
- Status: approved
The European Medicines Agency (EMA) has approved Ojemda, a medicinal product developed by Ipsen Pharma, for the treatment of paediatric low-grade glioma (LGG) in patients aged 6 months and older. This approval is based on the drug's efficacy and safety in patients with specific genetic mutations, including BRAF fusion or rearrangement, or BRAF V600 mutation. Ojemda is indicated for patients who have progressed after one or more prior systemic therapies.