SpringWorks : FDA Approves GOMEKLI For Treatment Of Adult And Pediatric Patients With NF1-PN

(RTTNews) - SpringWorks Therapeutics Inc. (SWTX) announced that the U.S. Food and Drug Administration has approved GOMEKLI (mirdametinib), SpringWorks MEK inhibitor, for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas not amenable to complete resection.

SpringWorks was granted a rare pediatric disease priority review voucher by the FDA.

GOMEKLI is available in 1 and 2 mg capsules and in a 1mg tablet for oral suspension, which dissolves easily in water. GOMEKLI is expected to be available through a specialty pharmacy and specialty distributor network in the United States within two weeks.

SpringWorks Marketing Authorization Application for mirdametinib for the treatment of children and adults with NF1-PN was validated by the European Medicines Agency (EMA) and is currently under review; a decision is expected from the European Commission in 2025.

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