SpringWorks Therapeutics announced on May 23, 2025, that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion. This opinion recommends conditional marketing authorization for mirdametinib for symptomatic, inoperable plexiform neurofibromas (PN) in pediatric and adult NF1 patients aged 2 years and above.
The European Commission (EC) is expected to make a final decision regarding the approval in the third quarter of 2025. If approved, mirdametinib would be the first and only therapy in the European Union with marketing authorization for both adults and children with NF1-PN.
The CHMP opinion was based on the primary results from the Phase 2b ReNeu trial, which demonstrated an objective response rate (ORR) of 41% in adults and 52% in children. This positive recommendation is a significant step towards expanding mirdametinib's availability beyond the U.S. market.
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