AstraZeneca’s FASENRA Gains FDA Approval for Add-On Maintenance Treatment of Severe Asthma in Children Aged 6-11

1. AstraZeneca's FASENRA (benralizumab) has received approval from the US Food and Drug Administration (FDA) for add-on maintenance treatment of severe eosinophilic asthma (SEA) in children aged 6 to 11.
2. The label expansion is supported by evidence from the TATE Phase III trial, as well as adequate and well-controlled trials in adult and adolescent populations.
3. FASENRA was initially approved in 2017 for the treatment of SEA in adults.
4. The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted in favor of the label expansion for younger patients.
5. FASENRA is a subcutaneous interleukin-5 (IL-5) receptor blocker.