SpringWorks Therapeutics, now a healthcare company of Merck, announced on July 18, 2025, that the European Commission (EC) granted conditional marketing authorization for EZMEKLY (mirdametinib). This approval is for symptomatic, inoperable plexiform neurofibromas (PN) in pediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.
EZMEKLY is the first and only therapy approved in the European Union (EU) for both adults and children with NF1-PN. NF1 affects approximately 3 in 10,000 people in the EU, or an estimated 135,000 individuals, representing a significant patient population.
The EC approval was based on results from the Phase 2b ReNeu trial, which demonstrated an objective response rate (ORR) of 41% in adults and 52% in children. This approval significantly expands the commercial potential of mirdametinib into the European market, providing a new treatment option for patients with high unmet medical needs.
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