Fasenra FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 2, 2024.
FDA Approved: Yes (First approved November 14, 2017)
Brand name: Fasenra
Generic name: benralizumab
Dosage form: Injection
Company: AstraZeneca
Treatment for: Asthma, Eosinophilic Granulomatosis with Polyangiitis
Fasenra (benralizumab) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody used for the treatment of eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.
- Fasenra is indicated for:
- add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype.
- treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
Development timeline for Fasenra
| Date | Article |
|---|---|
| Sep 18, 2024 | Approval Fasenra Approved in the US for Eosinophilic Granulomatosis with Polyangiitis |
| Apr 11, 2024 | Approval Fasenra Approved for Treatment of Children Aged 6 to 11 with Severe Asthma |
| Oct 4, 2019 | Approval FDA Approves Fasenra Pen (benralizumab) Pre-Filled Auto-Injector for Self-Administration |
| Nov 14, 2017 | Approval FDA Approves Fasenra (benralizumab) for Severe Eosinophilic Asthma |
Further information
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