Posted by Michael Wonder on 04 Mar 2024
SpringWorks Therapeutics initiates rolling submission of new drug application to the FDA for mirdametinib for the treatment of children and adults with NF1-PN
4 March 2024 - SpringWorks Therapeutics announced today that the Company has initiated a rolling submission of a new drug application to the US FDA for mirdametinib, an investigational MEK inhibitor, in paediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas.
The submission includes data from the Phase 2b ReNeu trial, a multi-center, open-label study that opened across 50 sites in the U.S. and enrolled 114 patients across two cohorts (pediatric and adult).
