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# Expanded Approval for AZ’s Koselugo
- URL: https://www.fdaweb.com/expanded-approval-for-azs-koselugo/
- Published: 2025-09-10T12:00:00.000Z
- Updated: 2026-09-14T15:21:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159841

FDA has approved AstraZeneca’s Koselugo (selumetinib) granules and capsules for pediatric patients one year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic inoperable plexiform neurofibromas (PN). The agency previously approved Koselugo for pediatric patients aged two and older with NF1 who have symptomatic, inoperable PN.

An agency [statement](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1?ref=fdaweb.com) says the expanded approval was based on adequate bridging between the oral granule and approved capsule formulations in a relative bioavailability study in healthy adults and exposure matching between the pediatric patient populations in the SPRINT Phase 2 Stratum 1 study and the SPRINKLE study. “Similar exposure between the formulations supports extrapolation of efficacy from pediatric patients at or greater than two years of age to those at or greater than one year of age,” the statement says.

The drug’s labeling includes Warnings and Precautions for cardiomyopathy, ocular toxicity, gastrointestinal toxicity, skin toxicity, increased creatine phosphokinase, increased levels of vitamin E and increased bleeding risk (Koselugo capsules), and embryo-fetal toxicity.

Koselugo had received breakthrough therapy and orphan drug designations.