🏅 FDA Orphan Designation

Gomekli

mirdametinib

Manufacturer: SpringWorks Therapeutics (EMD Serono / Merck KGaA)

Indicated for:

FDA-Approved Indications (1)

Neurofibromatosis type 1Orphan Designation

Adult and pediatric patients aged 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas not amenable to complete resection. Approved based on the ReNeu Pha…

Indications & Usage

1 INDICATIONS AND USAGE GOMEKLI is indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection [see Clinical Studies (14) ]. GOMEKLI is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. ( 1 )

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Gomekli

SpringWorks Therapeutics (EMD Serono / Merck KGaA)

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.