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Mirdametinib has the potential to be the first approved therapy for the treatment of adult patients and a best-in-class therapy for children with NF1-PN.
In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.
The FDA and the European Commission have previously granted Orphan Drug designation for mirdametinib for the treatment of NF1.
The FDA has also granted Fast Track designation for the treatment of patients ≥ 2 years of age with NF1-PN that are progressing or causing significant morbidity and Rare Pediatric Disease designation for the treatment of NF1.
Posted In: SWTX
