FDA has accepted the New Drug Application (NDA) from SpringWorks Therapeutics for mirdametinib for treating adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).
The NDA was granted Priority Review, and the FDA set a target action date of February 28, 2025, under the Prescription Drug User Fee Act (PDUFA).
Annette Bakker, CEO of the Children’s Tumor Foundation (CTF) and Board Chair of CTF Europe, acknowledged the FDA’s acceptance of SpringWorks NDA for mirdametinib for treating adult and pediatric patients with NF1-PN.
Bakker emphasized the urgent need for more treatment options for NF1-PN, particularly for adults who currently lack approved therapies.
She praised the FDA for granting Priority Review to mirdametinib, recognizing its potential as a significant improvement over existing treatment options.
Bakker concluded by expressing CTF’s commitment to working alongside SpringWorks to bring this vital new therapy to patients in the United States and Europe.
The FDA previously granted the designation of an orphan drug, fast track, and rare pediatric disease designation for mirdametinib for treating NF1.
Source: FDA Grants Priority Review to SpringWorks Therapeutics’ New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PN
https://ir.springworkstx.com/news-releases/news-release-details/fda-grants-priority-review-springworks-therapeutics-new-drug
