Posted by Michael Wonder on 02 Jul 2024
SpringWorks Therapeutics completes submission of new drug application to the FDA for mirdametinib for the treatment of children and adults with NF1-PN
1 July 2024 - SpringWorks Therapeutics announced today that the Company has completed the submission of a new drug application to the US FDA for mirdametinib, an investigational MEK inhibitor, for the treatment of paediatric and adult patients with neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN).
The new drug application submission includes data from the pivotal Phase 2b ReNeu trial, which evaluated mirdametinib in patients ≥ 2 years of age with NF1-associated PN causing significant morbidity.
