NUCALA
NUCALA (mepolizumab) is an interleukin-5 (IL-5) antagonist monoclonal antibody indicated for the treatment of several respiratory and inflammatory conditions characterized by an eosinophilic phenotype. It is approved as an add-on maintenance therapy for severe asthma in patients aged 6 and older, chronic rhinosinusitis with nasal polyps in adults, and inadequately controlled chronic obstructive pulmonary disease (COPD) in adults. The medication is also indicated for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) and for patients aged 12 and older with hypereosinophilic syndrome (HES). NUCALA is not intended for the relief of acute bronchospasm or status asthmaticus.
How NUCALA Works
Mepolizumab functions as an
Details
- Status
- Prescription
- First Approved
- 2015-11-04
- Routes
- SUBCUTANEOUS LYOPHILIZED POWER, SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
NUCALA Approval History
What NUCALA Treats
5 indicationsNUCALA is approved for 5 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Chronic Rhinosinusitis
- Chronic Obstructive Pulmonary Disease
- Eosinophilic Granulomatosis with Polyangiitis
- Hypereosinophilic Syndrome
NUCALA Competitors
Pro2 other drugs also target IL-5. Compare mechanisms, indications, and trial activity.
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.
NUCALA FDA Label Details
ProIndications & Usage
FDA Label (PDF)NUCALA is an interleukin-5 (IL-5) antagonist 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. • Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). • Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. • The treatment of adult patients with eosinophilic granulomatosis with polyangiiti...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.