REG - GSK PLC - EMA Filing acceptance for Nucala COPD

GSKAnnouncement

24/03/2025 07:15

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RNS Number : 8329B  GSK PLC  24 March 2025

Issued: 24 March 2025, London UK

 

GSK's application to expand use of Nucala (mepolizumab) for the treatment of
COPD accepted for review by the European Medicines Agency

 

·   Submission based on data from MATINEE trial, which showed a
statistically significant and clinically meaningful reduction in the
annualised rate of moderate/severe exacerbations with mepolizumab versus
placebo

·    Nucala (mepolizumab) could be the first biologic with monthly dosing
for patients with COPD, if approved

·   More than 40 million people in Europe live with COPD, one of the
leading causes of hospitalisation and death

 

 

 

GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency
(EMA) has accepted for review its application to expand the use of Nucala
(mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an
add-on maintenance treatment for patients with chronic obstructive pulmonary
disease (COPD) with an eosinophilic phenotype.

 

The application is supported by results from the positive phase III MATINEE
trial, which showed a statistically significant and clinically meaningful
reduction in the annualised rate of moderate/severe exacerbations with
mepolizumab compared to placebo. 1  (#_edn1) The trial recruited patients
across a wide spectrum of COPD phenotypes and clinical presentations. These
data indicate that mepolizumab, in addition to inhaled maintenance therapy,
offers a clinically meaningful benefit to a patient population in need of
treatments to reduce their risk of exacerbations. Results of MATINEE will be
presented at a future scientific congress.

 

IL-5 is a key cytokine (protein) in type 2 inflammation which is an underlying
driver in many diseases. 2  (#_edn2) (, 3  (#_edn3) , 4  (#_edn4) ) This type
of inflammation is detected in up to 40% of patients with COPD and is a major
cause of symptoms and exacerbations that can lead to hospitalisation and/or
emergency room visits.(2-4)

 

COPD affects more than 390 million people globally 5  (#_edn5) and over 40
million people in Europe 6  (#_edn6) . It is one of the leading causes of
hospitalisation in many countries 7  (#_edn7) . In 2021 alone, COPD had a
societal cost of approximately 164 billion euros and resulted in more than
330,000 deaths in Europe.(6) Recurrent exacerbations accelerate disease
progression and further increase the risk of hospitalisation, adding to
pressures on healthcare systems through emergency department visits and
inpatient care.(5, 8  (#_edn8) )

If approved, mepolizumab could be the first biologic with monthly dosing for
patients with COPD.

( )

Mepolizumab is currently approved for use in Europe across four IL-5 mediated
conditions. These include two respiratory indications as an add-on treatment
for severe refractory eosinophilic asthma in adults, adolescents and children
aged 6 years and older and as an add-on therapy with intranasal
corticosteroids for the treatment of adult patients with severe chronic
rhinosinusitis with nasal polyps for whom therapy with systemic
corticosteroids and/or surgery do not provide adequate disease control.
Indications also include the use of mepolizumab as an add-on treatment for
patients aged 6 years and older with relapsing-remitting or refractory
eosinophilic granulomatosis with polyangiitis (EGPA) and as an add-on
treatment for adult patients with inadequately controlled hypereosinophilic
syndrome without an identifiable non-haematologic secondary cause. 9  (#_edn9)

 

Mepolizumab is currently not approved for use in COPD in any country.

About the Nucala (mepolizumab) development programme for COPD

First approved in 2015 for severe asthma with an eosinophilic phenotype in the
US, mepolizumab is a monoclonal antibody that targets and binds to
interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2
inflammation. Mepolizumab has been developed for the treatment of a range of
IL-5 mediated diseases associated with type 2 inflammation.

 

The mepolizumab programme in COPD is comprised of three clinical trials. The
first two studies, METREX and METREO, completed in 2017. MATINEE was designed
to supplement METREX and METREO, building on our learnings from these studies
and IL-5 science to identify the patients who could benefit the most from
mepolizumab and support future submissions and approvals for use in this
indication. 10  (#_edn10)

 

MATINEE is a phase 3, randomized (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 for 52-104 weeks, versus placebo in
addition to inhaled triple therapy (dual long-acting bronchodilators plus
inhaled corticosteroid) in 804 patients with COPD, a history of exacerbations,
and evidence of type 2 inflammation characterised by raised blood eosinophil
count.(1)

 

The primary endpoint was met with the addition of Nucala to inhaled
maintenance therapy, showing a statistically significant and clinically
meaningful reduction in the annualised rate of moderate/severe exacerbations
versus placebo with patients treated for 52-104 weeks.(1)

 

For product and important safety information please consult the country
relevant summary of product characteristics. European 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)

 

About chronic obstructive pulmonary disease (COPD) and type 2 inflammation

COPD is a progressive and heterogeneous inflammatory lung disease that
includes chronic bronchitis and/or emphysema.(5) Type 2 inflammation is
present in a variety of immuno-inflammatory conditions and is a major
contributor to symptoms and exacerbations in up to 40% of people with
COPD. 11  (#_edn11) 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.(5)

 

Despite inhaled triple therapy, many patients experience persistent symptoms
and exacerbations, meaning there is a need for targeted therapies to address
the underlying pathophysiology linked to disease progression. Exacerbations
are acute episodes of worsening COPD symptoms and can result in
hospitalisation and irreversible lung damage that leads to progressive lung
function decline. For patients, this can result in a vicious cycle of
deterioration in overall physical health, which leads to worsening of symptoms
and quality of life, and increased mortality. Early intervention is important
in preventing exacerbations and cumulative lung damage.(5)

 

There is evidence to show IL-5 has broad effects on other structural and
immune and cell types beyond eosinophils, and how they contribute to
inflammation, which can lead to lung remodelling and disease progression.
Ongoing research is generating further evidence to understand the roles of
these cells and their potential contribution to clinical outcomes in patients
with respiratory diseases. Type 2 inflammation drives the underlying
dysfunction of various immune-mediated conditions. IL-5 is a key cytokine
(protein) in type 2 inflammation. The presence of type 2 inflammation can be
detected by blood eosinophil count, which measures the level of a type of
white blood cell. (2-4)

 

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, we are
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 to modify underlying
disease dysfunction and prevent disease 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.

 

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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 under
Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2024.

 

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 1  (#_ednref1) ClinicalTrials.gov. Mepolizumab as Add-on Treatment in
Participants With COPD Characterized by Frequent Exacerbations and Eosinophil
Level (MATINEE). Available at: https://clinicaltrials.gov/study/NCT04133909
(https://clinicaltrials.gov/study/NCT04133909) . Last accessed March 2025.

 2  (#_ednref2) Saha S, et al. Eosinophilic airway inflammation in COPD. Int J
Chron Obstruct Pulmon Dis. 2006;1(1):39-47.

 3  (#_ednref3) Maspero J, et al. Type 2 inflammation in asthma and other
airway diseases. ERJ Open Res. 2022;8:00576-2021.

 4  (#_ednref4) Singh D, et al. Eosinophilic inflammation in COPD: prevalence
and clinical characteristics. Eur Respir J. 2014;44:1697-1700.

 5  (#_ednref5) Global Initiative for Chronic Obstructive Lung Disease. 2024
Gold Report. Available at: https://goldcopd.org/2024-gold-report/
(https://goldcopd.org/2024-gold-report/) . Last accessed March 2025.

 6  (#_ednref6) International Respiratory Coalition. Chronic obstructive
pulmonary disease (COPD). Available at:
https://international-respiratory-coalition.org/diseases/copd/
(https://international-respiratory-coalition.org/diseases/copd/) . Last
accessed March 2025.

 7  (#_ednref7) The Health Policy Partnership. The state of COPD. Available
at: https://www.healthpolicypartnership.com/project/the-state-of-copd/
(https://www.healthpolicypartnership.com/project/the-state-of-copd/) .  Last
accessed March 2025.

 8  (#_ednref8) Hurst J R, et al. Susceptibility to Exacerbation in Chronic
Obstructive Pulmonary Disease. N Engl J Med. 2010;363:1128-38.

 9  (#_ednref9) 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 March 2025.

 10  (#_ednref10) Pavord ID, et al. Mepolizumab for Eosinophil-Associated
COPD: Analysis of METREX and METREO. Int J Chron Obstruct Pulmon Dis. 2021 Jun
16;16:1755-1770.

 11  (#_ednref11) Adeloye D, et al. NIHR RESPIRE Global Respiratory Health
Unit. Global, regional, and national prevalence of, and risk factors for,
chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and
modelling analysis. Lancet Respir Med. 2022 May;10(5):447-458.

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