Nucala
An injectable biological therapy used to treat severe eosinophilic asthma.
Where Mepolizumab is approved
All regulators →Of the three regulators tracked here, the first to approve Mepolizumab was the US, on 4 Nov 2015. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of Churg-Strauss syndrome (12 Mar 2013, withdrawn)
- 1 EU safety letter (DHPC), latest: medicine shortage for Nucala, 23 Jan 2021
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Mepolizumab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Mepolizumab works
All drug targets →- Interleukin-5 inhibitor InhibitorTarget: IL5 interleukin 5ChEMBL only
- Chronic obstructive pulmonary diseasePhase 3
- Chronic rhinosinusitis with nasal polypsPhase 3
- Eosinophilic granulomatosis with polyangiitisPhase 3
- Granulomatosis with polyangiitisPhase 3
- Nasal cavity polypPhase 3
- DysphagiaPhase 2
- Nasal polyposisPhase 2
- Atopic eczemaPhase 2
- Bullous pemphigoidPhase 2
- Coronary artery disorderPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2108429, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7685, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Mepolizumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Mepolizumab. 5 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Mepolizumab for maintenance treatment of uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils NICE TA1166 | Optimised | 17 Jun 2026 | Current |
| Mepolizumab for treating eosinophilic granulomatosis with polyangiitis (terminated appraisal) NICE TA845 | Terminated (no company submission) | 29 Nov 2022 | Current |
| Mepolizumab for treating severe hypereosinophilic syndrome (terminated appraisal) NICE TA846 | Terminated (no company submission) | 29 Nov 2022 | Current |
| Mepolizumab for treating severe chronic rhinosinusitis with nasal polyps (terminated appraisal) NICE TA847 | Terminated (no company submission) | 29 Nov 2022 | Current |
| Mepolizumab for treating severe eosinophilic asthma NICE TA671 | Optimised | 3 Feb 2021 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Mepolizumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 4 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: NucalaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Mepolizumab
- ChEMBL
- CHEMBL2108429
- DrugBank
- DB06612
- CAS number
- 196078-29-2
- FDA UNII
- 90Z2UF0E52
- Wikidata
- Q3306175
- Wikipedia
- Mepolizumab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Nucala is used for
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. ( 1.1 ) • Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.2 ) • Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. ( 1.3 ) • The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). ( 1.4 ) • 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. ( 1.5 ) Limitations of use: Not for relief of acute …
How it works
12.1 Mechanism of Action Mepolizumab is an IL-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Mepolizumab binds to IL-5 with a dissociation constant of 100 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface. Inflammation is an important component in the pathogenesis of asthma, CRSwNP, COPD, EGPA, and HES. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflam…
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 5 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.