Drug1st-line biologic line2 diseases
Omalizumab
Anti-IgE monoclonal antibody
- Response rate
- Significant NPS reduction
- Onset
- 4–8 weeks
- Route
- SC every 2–4 weeks (dose by IgE/weight)
- Line
- 1st-line biologic
- IgM effect
- Reduces polyp score
- Evidence level
- green
- Trial phase
- Phase 4
Used across diseases
| Disease | Response rate | Line | Evidence |
|---|---|---|---|
| Chronic Rhinosinusitis with Nasal Polyps | Significant NPS reduction | 1st-line biologic | green |
| Hypocomplementemic Urticarial Vasculitis Syndrome | Case reports suggest efficacy for urticarial symptoms | Investigational | red |
Evidence summary
Binds free IgE, preventing mast cell/basophil activation. POLYP 1 and POLYP 2 trials showed significant NPS improvement, reduced congestion, and improved SNOT-22. FDA-approved 2020 for CRSwNP. May be preferred in patients with high IgE and comorbid allergic asthma.
Approved indications
Conditions for which Omalizumab has regulatory approval (not specific to rare diseases covered here):
Moderate-to-Severe Allergic AsthmaChronic Idiopathic UrticariaChronic Rhinosinusitis with Nasal Polyps
Drug identifiers
| DrugBank | DB00043 ↗ |
| ATC Code | R03DX05 |
| Open Targets | CHEMBL1201576 ↗ |
Molecular targets
| Molecule | Role | Expression | Evidence |
|---|---|---|---|
| IgE | Allergic effector immunoglobulin | Elevated (local and systemic) | established |