omalizumab
Marketed as XOLAIR.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| BLA103976 | XOLAIR | 2003-06-20 | GENENTECH |
Manufacturers
GENENTECH
Common denial patterns
- IgE level thresholds (30-1500 IU/mL) for asthma indication
- Indication restriction (asthma vs CIU vs nasal polyps vs food allergy)
- Step therapy requiring trial of inhaled corticosteroid + LABA first
Specific notes
Brand: Xolair. Anti-IgE monoclonal antibody. FDA-approved for moderate-to-severe persistent allergic asthma, chronic idiopathic urticaria, nasal polyps, and food allergy IgE-mediated (February 2024 — first FDA-approved drug to reduce allergic reactions to multiple foods).
Genentech Access Solutions: https://www.xolair.com
Frequently asked questions
Why does insurance commonly deny omalizumab?
IgE level thresholds (30-1500 IU/mL) for asthma indication; Indication restriction (asthma vs CIU vs nasal polyps vs food allergy); Step therapy requiring trial of inhaled corticosteroid + LABA first.
When was omalizumab FDA approved?
Earliest FDA approval on record: 2003-06-20.
What brand names are sold as omalizumab?
XOLAIR.
Is there a patient assistance program for omalizumab?
Yes — Genentech Access Solutions at https://www.xolair.com.
What's specific to omalizumab?
Brand: Xolair. Anti-IgE monoclonal antibody. FDA-approved for moderate-to-severe persistent allergic asthma, chronic idiopathic urticaria, nasal polyps, and food allergy IgE-mediated (February 2024 — first FDA-approved drug to reduce allergic reactions to multiple foods).
Related
Sources
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