BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - Ipsen (IPN.PA, I7G.F) announced that the European Commission has granted conditional marketing authorization for Ojemda as monotherapy for the treatment of patients 6 months of age and older with pediatric low-grade-glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies. The EC approval is based on data from the pivotal Phase II FIREFLY-1 study.
Ipsen noted that Ojemda is the first medicine to undergo a JCA evaluation. The EU HTA Regulation, which began phasing in from January 2025, introduced a new Joint Clinical Assessment or JCA process to streamline and harmonize the comparative clinical evidence review across EU Member States.
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