Posted by Michael Wonder on 25 May 2025
SpringWorks Therapeutics receives positive CHMP opinion for mirdametinib for the treatment of adult and paediatric patients with NF1-PN
23 May 2025 - If approved, mirdametinib is expected to be the first and only therapy in the European Union with marketing authorisation for both adults and children with NF1-PN.
SpringWorks Therapeutics announced today that the EMA's CHMP has adopted a positive opinion recommending the granting of a conditional marketing authorisation for mirdametinib, a MEK inhibitor, for the treatment of symptomatic, inoperable plexiform neurofibromas in paediatric and adult patients with neurofibromatosis type 1 aged 2 years and above.
