REG - GSK PLC - Nucala COPD approved by the European Commission

GSKAnnouncement

06/02/2026 07:00

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RNS Number : 9743R  GSK PLC  06 February 2026

Issued: 6 February 2026, London UK

 

Nucala (mepolizumab) approved by the European Commission for the treatment of
chronic obstructive pulmonary disease (COPD)

 

·   Approval based on results from MATINEE showing significant reduction in
the rate of moderate/severe exacerbations versus placebo

·   Nucala is the first and only monthly biologic in the EU evaluated in a
wide COPD population with an eosinophilic phenotype

·   MATINEE data showed a reduction in exacerbations leading to emergency
department visits and/or hospitalisations versus placebo

 

 

 

GSK plc (LSE/NYSE: GSK) today announced the European Commission has approved
Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), in
adults as an add-on maintenance treatment for uncontrolled COPD characterised
by raised blood eosinophils on a combination of an inhaled corticosteroid
(ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic
antagonist (LAMA).

 

The approval was based on data from the positive MATINEE phase III trial in
which mepolizumab showed a clinically meaningful and statistically significant
reduction in the annualised rate of moderate/severe exacerbations versus
placebo plus standard of care in a wide spectrum of COPD patients with an
eosinophilic phenotype.(1)

 

COPD affects over 390 million people, including about 40 million in
Europe.(2,3) Globally, it is projected to be the leading cause of hospital
admissions over the next decade.(4) If hospitalised due to COPD, one in ten
patients will die during the stay, up to one in four over the next year and
half will lose their lives within five years.(5,6) Nucala is the first
biologic with pre-specified phase III data showing a reduction in the
annualised rate of exacerbations leading to emergency department visits and/or
hospitalisation versus placebo.(1)

 

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology &
Inflammation R&D, GSK, said: "For the first time, adults with uncontrolled
COPD characterised by raised blood eosinophils in the EU will have the option
for a monthly biologic shown to significantly reduce exacerbations, which can
lead to irreversible lung damage, hospitalisations and emergency department
visits. Nucala could offer relief to the millions of Europeans who need
additional options beyond inhaled triple therapy to manage their COPD."

 

Susanna Palkonen, Director, European Federation of Allergy and Airways
Diseases Patients' Associations (EFA), said: "The burden for patients living
with COPD is immense, especially for those facing continued exacerbations and
repeated hospitalisations. We welcome, and our community celebrates, new
treatment options for COPD patients as they are desperately needed."

 

In MATINEE, mepolizumab demonstrated a statistically significant reduction in
the annualised rate of moderate or severe exacerbations compared with placebo,
both in addition to inhaled triple therapy [rate ratio 0.79, 95% confidence
interval (0.66, 0.94), P=0.01] (AER mepolizumab = 0.80 exacerbations per year
versus placebo = 1.01).(1) The MATINEE trial studied mepolizumab in a wide
spectrum of patients with an eosinophilic phenotype including chronic
bronchitis, emphysema only or a combination of both.

 

In a pre-defined secondary endpoint, the annualised rate of COPD exacerbations
requiring ED visits and/or hospitalisation was reduced in the mepolizumab
group when compared with placebo [rate ratio 0.65; 95% CI (0.43, 0.96)
nominally significant after adjustment for multiplicity] (AER mepolizumab =
0.13 exacerbations per year versus placebo = 0.20).(1) The incidence of
adverse events were similar between mepolizumab and placebo (mepolizumab vs
placebo: 74% vs 77%). The full results from the MATINEE phase III trial were
published in The New England Journal of Medicine
(https://www.nejm.org/doi/10.1056/NEJMoa2413181) in April 2025 with further
data presented at the 2025 American Thoracic Society International
Congress.(1)

 

In addition to COPD, Nucala is approved in Europe across four other diseases
driven by underlying type 2 inflammation, including severe asthma, chronic
rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with
polyangiitis (EGPA), and hypereosinophilic syndrome (HES). It has also been
approved for COPD in the US, UK, and China.

 

About COPD

COPD is a progressive and heterogeneous inflammatory lung disease that
includes chronic bronchitis and/or emphysema.(2) It affects more than 390
million people globally and is the third leading cause of
death.(2,7) Patients with COPD experience persistent respiratory symptoms
such as breathlessness, cough, and sputum along with progressive airflow
obstruction due to the chronic inflammation, that impact daily life.(2)

 

Despite inhaled triple therapy, many patients experience persistent symptoms
and exacerbations.(8) A proportion of these patients have elevated type 2
inflammation, characterised by raised BEC. This inflammation contributes to
the higher risk of exacerbations, or acute episodes of worsening COPD
symptoms, which can result in hospitalisation and irreversible lung
damage.(2) Early intervention is important in preventing exacerbations and
cumulative lung damage.(2)

 

About MATINEE

MATINEE is a phase III, randomised (1:1), double-blind, parallel-group trial
assessing the efficacy and safety of mepolizumab 100 mg as add-on therapy,
administered subcutaneously every 4 weeks versus placebo in addition to
optimal inhaled triple therapy (dual long-acting bronchodilators plus inhaled
corticosteroid).(1,8) MATINEE assessed the efficacy and safety of mepolizumab
in patients with COPD with evidence of type 2 inflammation, characterised by a
raised blood eosinophil count (≥300 cells/µL). Patients could participate
with a range of clinical presentations of COPD including chronic bronchitis,
emphysema only or a combination of both. The full analysis of MATINEE included
403 patients enrolled on the mepolizumab arm and 401 on placebo, all of whom
had experienced exacerbations in the previous year despite receiving optimised
inhaled maintenance therapy.(1)

 

About Nucala (mepolizumab)

Nucala is a monoclonal antibody that targets and binds to IL-5. Nucala has
been developed for the treatment of a range of diseases with underlying type
2 inflammation. Nucala is approved for use in Europe across five indications,
including severe asthma, CRSwNP, EGPA, HES and COPD.(9)

 

For product and important safety information please consult the country's
relevant summary of product characteristics. The EU Prescribing Information
is available at: NUCALA-EPAR-PRODUCT-INFORMATION_EN.PDF
(https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf)
 

 

About GSK in respiratory

GSK continues to build on decades of pioneering work to deliver more ambitious
treatment goals, develop the next generation standard of care, and redefine
the future of respiratory medicine for hundreds of millions of people with
respiratory diseases. With an industry-leading respiratory portfolio and
pipeline of vaccines, targeted biologics, and inhaled medicines, GSK is
focused on improving outcomes and the lives of people living with all types of
asthma and COPD along with less understood refractory chronic cough or rarer
conditions like systemic sclerosis with interstitial lung disease. GSK is
harnessing the latest science and technology with the aim of modifying the
underlying disease dysfunction and preventing progression.

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at www.gsk.com
(https://www.gsk.com) .

 

 GSK enquiries
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                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco   +1 215 751 3126       (Philadelphia)

 

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described in
the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q4 Results for 2025.

 

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References

1 Sciurba F, et al. Mepolizumab to prevent exacerbations in COPD with an
eosinophilic phenotype. N Engl J Med. Apr 2025;392:1710-1720. Available at
https://www.nejm.org/doi/10.1056/NEJMoa2413181
(https://www.nejm.org/doi/10.1056/NEJMoa2413181)

2 Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2026 Gold
Report. Available at: https://goldcopd.org/2026-gold-report-and-pocket-guide/
(https://goldcopd.org/2026-gold-report-and-pocket-guide/) . Last accessed
November 2025.

3 European Respiratory Society. (2023). Introductions.
https://www.ersnet.org/wp-content/uploads/2023/01/Introductions.pdf
(https://www.ersnet.org/wp-content/uploads/2023/01/Introductions.pdf)

4 Khakban, Amir et al. "The Projected Epidemic of Chronic Obstructive
Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based
Perspective." American journal of respiratory and critical care medicine vol.
195,3 (2017): 287-291. doi:10.1164/rccm.201606-1162PP. Accessed April 2025.

5 Waeijen-Smit K, et al. Global mortality and readmission rates following COPD
exacerbation-related hospitalisation: a meta-analysis of 65 945 individual
patients. ERJ Open Res. 2024 Feb 26;10(1):00838-2023. doi:
doi.org/10.1183/23120541.00838-2023

6 van Hirtum PV, et al. Long term survival after admission for COPD
exacerbation: A comparison with the general population. Respir Med.
2018;137:77-82. doi:10.1016/j.rmed.2018.02.015

7 Chen S, et al. The global economic burden of chronic obstructive pulmonary
disease for 204 countries and territories in 2020-50: a health-augmented
macroeconomic modelling study. Lancet Glob Health. 2023;11(8):e1183-e1193.
DOI: 10.1016/S2214-109X(23)00217-6.

8 Pavord ID, et al. Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary
Disease. N Engl J Med. Oct 2017;377:1613-1629. DOI: 10.1056/NEJMoa1708208.

9 European Medicines Authority. Nucala prescribing information. Available at:
https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf
(https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf)
. Last accessed January 2026.

 

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