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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

Jan 22, 2022Approval FDA Approves Nucala (mepolizumab) 40 mg Prefilled Syringe for Children with Severe Eosinophilic Asthma
Jul 29, 2021Approval GSK Announces FDA Approval for Nucala (mepolizumab) for use in Adults with Chronic Rhinosinusitis with Nasal Polyps
Sep 25, 2020Approval FDA Approves Nucala (mepolizumab) as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)
Sep 12, 2019Approval FDA Approves Nucala (mepolizumab) for Six to 11-Year-Old Children with Severe Eosinophilic Asthma
Jun  6, 2019Approval Nucala (mepolizumab) Gains FDA Approval for Two New Self-Administration Options
Dec 12, 2017Approval FDA Approves Nucala (mepolizumab) for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome)
Nov  4, 2015Approval FDA Approves Nucala (mepolizumab) to Treat Severe Asthma
Jun 11, 2015GSK Announces Outcome of US FDA Advisory Committee Recommending Approval of Mepolizumab for Severe Asthma
Nov  5, 2014GSK Announces Regulatory Submissions for Mepolizumab in Severe Eosinophilic Asthma

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.