Nucala FDA Approval History

Last updated by Judith Stewart, BPharm on May 26, 2025.

FDA Approved: Yes (First approved November 4, 2015)
Brand name: Nucala
Generic name: mepolizumab
Dosage form: Injection
Company: GlaxoSmithKline
Treatment for: Asthma, Chronic Rhinosinusitis With Nasal Polyps, COPD, 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, chronic obstructive pulmonary disease, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.

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 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 polyangiitis (EGPA).
- the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for greater than or equal to 6 months without an identifiable non-hematologic secondary cause.
Nucala is not indicated for the 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 (incidence ≥5%):
- in asthma patients include headache, injection site reaction, back pain, and fatigue.
- in CRSwNP patients include oropharyngeal pain and arthralgia.
- in COPD patients include back pain, diarrhea, and cough.
- in EGPA and HES patients include headache, injection site reaction, back pain, and fatigue.

Development timeline for Nucala

Date	Article
May 22, 2025	Approval Nucala (mepolizumab) Approved by US FDA for Use in Adults with Chronic Obstructive Pulmonary Disease (COPD)
Jan 22, 2022	Approval FDA Approves Nucala (mepolizumab) 40 mg Prefilled Syringe for Children with Severe Eosinophilic Asthma
Jul 29, 2021	Approval GSK Announces FDA Approval for Nucala (mepolizumab) for use in Adults with Chronic Rhinosinusitis with Nasal Polyps
Sep 25, 2020	Approval FDA Approves Nucala (mepolizumab) as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)
Sep 12, 2019	Approval FDA Approves Nucala (mepolizumab) for Six to 11-Year-Old Children with Severe Eosinophilic Asthma
Jun 6, 2019	Approval Nucala (mepolizumab) Gains FDA Approval for Two New Self-Administration Options
Dec 12, 2017	Approval FDA Approves Nucala (mepolizumab) for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome)
Nov 4, 2015	Approval FDA Approves Nucala (mepolizumab) to Treat Severe Asthma
Jun 11, 2015	GSK Announces Outcome of US FDA Advisory Committee Recommending Approval of Mepolizumab for Severe Asthma
Nov 5, 2014	GSK Announces Regulatory Submissions for Mepolizumab in Severe Eosinophilic Asthma

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Nucala FDA Approval History

Development timeline for Nucala

See also

Further information