OJEMDA Ipsen Pty Ltd
Product name
OJEMDA
Sponsor
Accepted date
Jul-2026
Active ingredients
tovorafenib
Summary of proposed indication
OJEMDA (tovorafenib) is proposed as a standalone treatment in patients 6 months or older with paediatric low-grade glioma, a type of slow-growing brain tumour. It is intended for patients whose tumour has certain changes in the BRAF gene, called a BRAF fusion, BRAF rearrangement or BRAF V600 mutation, and who have already had at least one other whole-body treatment.
Application type
A (new medicine)
Publication date
Jul-2026
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration.