Nucala FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 6, 2021.
FDA Approved: Yes (First approved November 4, 2015)
Brand name: Nucala
Generic name: mepolizumab
Dosage form: Injection
Company: GlaxoSmithKline
Treatment for: Eosinophilic Asthma; Chronic Rhinosinusitis with Nasal Polyps; Eosinophilic Granulomatosis with Polyangiitis; Hypereosinophilic Syndrome
Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) used for the treatment of with severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), and hypereosinophilic syndrome (HES).
- Nucala is 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 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).
- The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
- The treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.
Limitations of use: Not for relief of acute bronchospasm or status asthmaticus.
- Nucala is administered via subcutaneous injection once every 4 weeks.
- Nucala can cause serious adverse reactions including hypersensitivity reactions and herpes zoster infections.
- Common adverse reactions include: headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and tiredness (fatigue). Mouth/throat pain and joint pain have been reported with CRSwNP.
Development timeline for Nucala
Further information
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