dupilumab
Marketed as DUPIXENT.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| BLA761055 | DUPIXENT | 2017-03-28 | REGENERON PHARMACEUTICALS |
Manufacturers
REGENERON PHARMACEUTICALS
Common denial patterns
- Severity threshold (EASI score requirements)
- Step therapy requiring topicals first
- Indication restrictions (atopic dermatitis vs asthma vs nasal polyposis)
Specific notes
Multiple FDA indications: atopic dermatitis, asthma, eosinophilic esophagitis, nasal polyposis, prurigo nodularis. Each indication has separate prior auth criteria.
Dupixent MyWay: https://www.dupixent.com
Frequently asked questions
Why does insurance commonly deny dupilumab?
Severity threshold (EASI score requirements); Step therapy requiring topicals first; Indication restrictions (atopic dermatitis vs asthma vs nasal polyposis).
When was dupilumab FDA approved?
Earliest FDA approval on record: 2017-03-28.
What brand names are sold as dupilumab?
DUPIXENT.
Is there a patient assistance program for dupilumab?
Yes — Dupixent MyWay at https://www.dupixent.com.
What's specific to dupilumab?
Multiple FDA indications: atopic dermatitis, asthma, eosinophilic esophagitis, nasal polyposis, prurigo nodularis. Each indication has separate prior auth criteria.
Related
Sources
Appeal a dupilumab 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