REG - GSK PLC - Nucala receives positive CHMP opinion for COPD

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RNS Number : 4027L  GSK PLC  12 December 2025

Issued: 12 December 2025, London UK

 

Nucala (mepolizumab) receives positive CHMP opinion for treatment of chronic
obstructive pulmonary disease (COPD)

 

·   Positive opinion based on MATINEE phase III trial showing significant
reduction in COPD exacerbations versus placebo in addition to inhaled triple
therapy

·   Nucala is the only monthly biologic studied in a wide COPD population
with an eosinophilic phenotype

·   Nucala could offer a new option to millions of Europeans who remain
uncontrolled on inhaled triple therapy and have a raised blood eosinophil
count

 

 

GSK plc (LSE/NYSE: GSK) today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) has
recommended the approval of Nucala (mepolizumab), a monoclonal antibody
targeting interleukin-5 (IL-5), in adults as an add-on maintenance treatment
for uncontrolled chronic obstructive pulmonary
disease (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 European Commission decision on approval is expected in Q1 2026.

 

Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology &
Inflammation R&D, GSK said: "People living with uncontrolled COPD with an
eosinophilic phenotype continue to experience exacerbations that can lead to
irreversible lung damage and avoidable hospitalisations and emergency
department visits. Preventing these events is crucial to slowing the
progression of disease and today's CHMP recommendation brings us closer to
providing Nucala to patients who are in need of new options."

 

COPD affects more than 40 million people in Europe and more than 390 million
people globally.(1,2) It is estimated that over 35% of COPD patients who are
inadequately controlled on inhaled triple therapy have a raised blood
eosinophil count (BEC) of at least 300 cells/μL.(3) Recurrent exacerbations
accelerate disease progression and add to pressure on healthcare systems
through unplanned and unpredictable emergency department visits and inpatient
care.(2,4 ) In 2021 alone, COPD had a societal cost of approximately 164
billion euros and resulted in more than 330,000 deaths in Europe.(5)

 

The positive opinion is based on data from the MATINEE phase III trial in
which 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).(6,7) 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. The incidence of adverse
events were similar between mepolizumab and placebo (mepolizumab vs placebo:
74% vs 77%).

 

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).(6) Mepolizumab 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.

 

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).(6,7)

 

MATINEE assessed the efficacy and safety of mepolizumab for 52-104 weeks, in
804 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 condition of patients ranged in
severity from moderate to very severe, or stages 2-4 as assessed by the
medically recognised scale of Global Initiative for Chronic Obstructive Lung
Disease (GOLD). 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.(6)

 

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 currently approved for use in Europe across four
indications, including severe asthma, chronic rhinosinusitis with nasal polyps
(CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA) and
hypereosinophilic syndrome (HES).(8) It was approved in the US for COPD, its
fifth indication, in May 2025.

( )

For product and important safety information please consult the country's
relevant summary of product characteristics. The EU and UK 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 gsk.com.

 

 GSK enquiries
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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 Q3 Results for 2025.

 

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References

1.     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)

2.     Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2026
Gold Report. Available at: goldcopd.org. Last accessed November 2025.

3.     GSK, Optum Analysis DOF (DOF 2024N562932_00).

4.     Hurst J R, et al. Susceptibility to Exacerbation in Chronic
Obstructive Pulmonary Disease. N Engl J Med. 2010;363:1128-38.

5.     International Respiratory Coalition. Chronic obstructive pulmonary
disease (COPD). Available at:
https://international-respiratory-coalition.org/diseases/copd/. Last accessed
March 2025.

6.     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
nejm.org.

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

8.     European Medicines Authority. Nucala prescribing information.
Available at:
https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf.
Last accessed March 2025.

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