benralizumab
Marketed as FASENRA.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| BLA761070 | FASENRA | 2017-11-14 | ASTRAZENECA AB |
Manufacturers
ASTRAZENECA AB
Common denial patterns
- Eosinophil count threshold (≥300 cells/µL within 12 months)
- Step therapy requiring mepolizumab first within IL-5 class
- Indication restriction (severe asthma vs EGPA — December 2024)
Specific notes
Brand: Fasenra. IL-5 receptor α monoclonal antibody. Approved for severe eosinophilic asthma; expanded to eosinophilic granulomatosis with polyangiitis (EGPA) September 2024.
Benra360 Patient Support: https://www.fasenra.com/patient/savings-and-support.html
Frequently asked questions
Why does insurance commonly deny benralizumab?
Eosinophil count threshold (≥300 cells/µL within 12 months); Step therapy requiring mepolizumab first within IL-5 class; Indication restriction (severe asthma vs EGPA — December 2024).
When was benralizumab FDA approved?
Earliest FDA approval on record: 2017-11-14.
What brand names are sold as benralizumab?
FASENRA.
Is there a patient assistance program for benralizumab?
Yes — Benra360 Patient Support at https://www.fasenra.com/patient/savings-and-support.html.
What's specific to benralizumab?
Brand: Fasenra. IL-5 receptor α monoclonal antibody. Approved for severe eosinophilic asthma; expanded to eosinophilic granulomatosis with polyangiitis (EGPA) September 2024.
Related
Sources
Appeal a benralizumab denial
Upload your denial — DenialHelp drafts a physician-ready appeal letter in five minutes with the right clinical guideline and federal regulation cited. $39 first-level, money back if we can't draft a strong appeal.
Get started →Contact: hello@denialhelp.com