Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1
The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population
The programme features headline data from pivotal Phase III trials, including PREVAIL in gMG, KOMET in NF1-PN, and CHAMPION-NMOSD, alongside real-world evidence supporting established therapies
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