Ojemda (tovorafenib)
- Region
- 🇪🇺 EU
- Active substance
- tovorafenib
- Company
- Ipsen Pharma
- Status
- Authorised
- Therapeutic area
- Glioma
- CHMP opinion
- Thu 26 Feb 2026
- EU approval
- Mon 20 Apr 2026
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/006140
- ATC
- L01EC04
- Official record
- www.ema.europa.eu
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)
Regulatory milestones
Ojemda (tovorafenib) approved in the EU
Marketing authorisation to Ipsen Pharma; Orphan, Conditional, Additional monitoring · source
Ojemda (tovorafenib): CHMP positive opinion
Ipsen Pharma; Orphan, Conditional, Additional monitoring · source
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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.