Ipsen receives Brussels approval for pediatric glioma treatment
Ipsen has announced that the European Commission has granted conditional marketing authorization for Ojemda (tovorafenib) as the first targeted therapy for recurrent or refractory pediatric low-grade glioma, regardless of BRAF gene alteration.
The drug is approved as a monotherapy for patients aged 6 months and older with pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or a BRAF V600 mutation, who have progressed following at least one prior systemic therapy.
This EC decision applies across all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway. More than 800 children are diagnosed each year with BRAF-altered pediatric low-grade glioma in the EU.
While classified as low-grade (slow-growing), this type of brain tumor frequently leads to significant physical and neurological impairments, including vision loss, speech difficulties, and motor dysfunction, according to Ipsen.
The Brussels approval is based on data from the pivotal Phase II FIREFLY-1 study, which evaluated tovorafenib in 137 children and young adults, demonstrating significant and durable tumor responses.
Ipsen specialises in the research, development, manufacture and marketing of specialty medicines. Net sales by therapeutic area break down as follows:
- oncology (69.2%);
- neuroscience (20.3%);
- rare diseases (10.5%).
At the end of 2025, the group had 7 research and development centers located in France (2), the United Kingdom (2), China (2) and Ireland, and 5 manufacturing sites worldwide.
Net sales are distributed geographically as follows: France (8%), Europe (31.7%), the United States (32.9%), North America (2.2%) and other (25.2%).
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