🏅 FDA Orphan Designation

Koselugo

selumetinib

Manufacturer: AstraZeneca / Alexion

Indicated for:

Neurofibromatosis type 1OrphanMosaic neurofibromatosis type 1Orphan

FDA-Approved Indications (2)

Neurofibromatosis type 1Orphan Designation

Pediatric patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas. Initially approved April 10, 2020. CONTEXT: selumetinib was initially…

Mosaic neurofibromatosis type 1Orphan Designation

treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)

Indications & Usage

1 INDICATIONS AND USAGE KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). ( 1 )

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KOSELUGO

AstraZeneca

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Koselugo

AstraZeneca / Alexion

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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.