CHMP positive opinion per il primo medicinale sottoposto a valutazione clinica congiunta (JCA) secondo il Regolamento EU-HTA

Ipsen's Ojemda (tovorafenib) - to treat patients aged 6 months and older with paediatric low-grade glioma (a type of non-cancerous brain tumour -  received positive CHMP opinion https://www.ema.europa.eu/en/news/new-medicine-treat-paediatric-low-grade-glioma, and will be the first product to have a JCA report (the JCA Report is in the drafting phase at this point in time).

The expected timeline for the corresponding JCA Report is as follows: 

• + 67 days: expected EC decision on marketing authorisation.
• +30 days from EC decision: the JCA-R must be endorsed by the Member States HTA Coordination Group no later than 30 days after the EC decision.
• +10 days: following this, the HTA Secretariat in the EU Commission has 10 days to publish the JCA-R. 

As a result, the JCA Report is expected to be released during the month of May 2026.