FASENRA
FASENRA (benralizumab) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody. It is indicated as an add-on maintenance treatment for adult and pediatric patients aged 6 years and older with severe asthma and an eosinophilic phenotype. Additionally, the medication is approved for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). It is not intended for the relief of acute bronchospasm or status asthmaticus.
How FASENRA Works
Benralizumab binds directly to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) located on the surface of eosinophils and basophils. This binding facilitates an interaction with immune effector cells, such as natural killer cells, to trigger antibody-dependent cell-mediated cytotoxicity (ADCC). This process leads to the apoptosis, or programmed cell death, of eosinophils and basophils. By reducing these cell types, the drug addresses a key component of the inflammation associated with asthma and EGPA.
Details
- Status
- Prescription
- First Approved
- 2017-11-14
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
FASENRA Approval History
What FASENRA Treats
2 indicationsFASENRA is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Eosinophilic Granulomatosis with Polyangiitis
FASENRA Competitors
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Competitors share the same molecular target (IL-5). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FASENRA FDA Label Details
ProIndications & Usage
FDA Label (PDF)FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) 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). Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. 1.1 Asthma FASENRA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.