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Astrazeneca Receives FDA Approval for Selumetinib for Pediatric Patients With Neurofibromatosis Type 1
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Astrazeneca Receives FDA Approval for Selumetinib for Pediatric Patients With Neurofibromatosis Type 1
Sep 10, 2025 8:49 AM

11:19 AM EDT, 09/10/2025 (MT Newswires) -- Astrazeneca ( AZN ) has received the US Food and Drug Administration's approval for selumetinib granules and capsules as treatment for pediatric patients of at least 1 year old with neurofibromatosis type 1, who have symptomatic, inoperable plexiform neurofibromas, according to an FDA statement Wednesday.

According to the FDA, the approval was based on "adequate bridging" between selumetinib's granule and capsule formulations evidenced in a study conducted in healthy adults and exposure matching between pediatric patient populations of a capsule formulation study and an oral granule formulation study.

Selumetinib is also approved for the same indication in pediatric patients aged 2 years and above, the FDA said.

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