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# Fasenra OK’d for Pediatric Severe Asthma
- URL: https://www.fdaweb.com/fasenra-okd-for-pediatric-severe-asthma/
- Published: 2024-04-11T12:00:00.000Z
- Updated: 2026-09-14T14:28:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156758

FDA has approved an AstraZeneca supplemental BLA for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe asthma aged 6 to 11 years with an eosinophilic phenotype. The drug was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma in patients aged 12 years and older.

The new indication was approved based on data from TATE, an open-label, multinational, non-randomized, parallel assignment Phase 3 trial, as well as adequate and well-controlled trials in adult and adolescent populations.