REG - GSK PLC - Nucala COPD submission accepted in China

GSKAnnouncement

20/02/2025 07:15

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RNS Number : 7762X  GSK PLC  20 February 2025

Issued: 20 February 2025, London UK

 

Nucala (mepolizumab) application for COPD accepted for review in China

 

·   Around 100 million people live with COPD in China, accounting for
almost 25% of all COPD cases globally

·   Submission based on data from MATINEE trial, which showed a significant
and clinically meaningful reduction in rate of moderate/severe exacerbations
with Nucala compared to placebo

·   Data includes positive results in the broadest COPD population studied
with a biologic, including those with chronic bronchitis, emphysema only, or
both

·   Nucala could be the first approved biologic with monthly dosing for
patients with COPD

 

 

GSK plc (LSE/NYSE: GSK) today announced that the China National Medical
Products Administration has accepted for review the new drug application for
the use of Nucala (mepolizumab), a monoclonal antibody that targets
interleukin-5 (IL-5), as add-on maintenance treatment for patients with
chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

 

IL-5 is a key cytokine (protein) in type 2 inflammation which is an underlying
driver in many diseases. (2-4) 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, with research estimating
that approximately 100 people in China live with COPD, which accounts for
almost 25% of the global COPD cases.(5,6) This puts a significant burden on
healthcare resources and the lives of patients, with recurrent exacerbations
accounting for a large proportion of the annual direct medical costs of COPD
due to emergency department visits and inpatient care.(5-7) This burden is
expected to dramatically increase due to the rapidly aging population in
China.(6,7)

 

Nucala's application was supported by results from the positive Phase III
MATINEE trial which showed a significant and clinically meaningful reduction
in rate of moderate/severe exacerbations with Nucala compared to placebo. The
trial recruited a wide spectrum of COPD patients including those with chronic
bronchitis, emphysema-only or both.(1) These data indicate that Nucala, 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.

 

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

( )

Nucala is currently approved for use in the China across three IL-5 mediated
conditions. These include two respiratory indications as an add-on maintenance
treatment for severe eosinophilic asthma in adults and adolescents aged 12
years and older and as an add-on therapy with intranasal corticosteroids for
the treatment of adult patients with 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 Nucala for the
treatment of adult patients with eosinophilic granulomatosis with polyangiitis
(EGPA).

 

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

 

 

 

About the Nucala 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.(8) Nucala has been developed for the treatment of a range of
IL-5 mediated diseases associated with type 2 inflammation.(8)

 

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
Nucala and support future submissions and approvals for use in this
indication.(9)

 

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.

 

Data from MATINEE will be presented at a future scientific congress or in a
peer reviewed journal. Global regulatory submissions including MATINEE data
are ongoing.

 

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. It affects more than 390 million
people globally and is the third leading cause of death resulting in more than
3 million deaths annually.(5,10) 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.(10)

 

Exacerbations are acute episodes of worsening COPD symptoms and can result in
hospitalisation and irreversible lung damage that leads to progressive lung
function decline.(10-12) 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.(10-12) 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.(10-12)

 

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.(10-13) Permanent
and irreversible tissue damage seen in patients with advanced disease make it
challenging to provide further improvements in respiratory symptoms and
quality of life and is the reason why early intervention is so important in
preventing exacerbations and cumulative lung damage.(10)

 

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.(2,3,14-18) 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.(2-4) 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 2023, and
GSK's Q4 Results for 2024.

 

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References

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

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

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

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

5.   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.

6.   World Health Organisation (WHO).Advancing COPD care in China through a
comprehensive approach. Available at:
https://www.who.int/news-room/feature-stories/detail/advancing-copd-care-in-china-through-a-comprehensive-approach#:~:text=China%20has%20almost%20100%20million%20people%20living%20with,for%20more%20than%200.9%20million%20deaths%20in%202013
(https://www.who.int/news-room/feature-stories/detail/advancing-copd-care-in-china-through-a-comprehensive-approach#:~:text=China%20has%20almost%20100%20million%20people%20living%20with,for%20more%20than%200.9%20million%20deaths%20in%202013)
. Last accessed February 2025

7.   Yin P, et al. The Burden of COPD in China and Its Provinces: Findings
From the Global Burden of Disease Study 2019. Front Public Health. 2022 Jun
3;10:859499.

8.   Nucala US information available at:
https://www.accessdata.fda.gov/drugsatda_docs/label/2017/125526s004lbl.pdf
(https://www.accessdata.fda.gov/drugsatda_docs/label/2017/125526s004lbl.pdf)
last accessed February 2025

9.   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.

10.  The Global Strategy for Diagnosis, Management and Prevention of COPD
2024. Available at: www.goldcopd.org (http://www.goldcopd.org) Last accessed:
November 2024.

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

12.  Whittaker H, et al. Frequency and Severity of Exacerbations of COPD
Associated with Future Risk of Exacerbations and Mortality: A UK Routine
Health Care Data Study. Int J Chron Obstruct Pulmon Dis. 2022;17:427-437.

13.  Rabe KF, et al. Targeting Type 2 Inflammation and Epithelial Alarmins in
Chronic Obstructive Pulmonary Disease: A Biologics Outlook. Am J Respir Crit
Care Med. 2023;208(4):395-405.

14.  Buchheit KM, et al. Mepolizumab targets multiple immune cells in
aspirin-exacerbated respiratory disease. J Allergy Clin Immunol.
2021;148(2):574-584.

15.  Barretto KT, et al. Human airway epithelial cells express a functional
IL-5 receptor. Allergy. 2020;75(8):2127-2130.

16.  Bajbouj K, et al. IL-5 receptor expression in lung fibroblasts:
Potential role in airway remodelling in asthma. Allergy. 2023;78(3):882-885.

17.  Siddiqui S, et al. Eosinophils and tissue remodeling: Relevance to
airway disease. J Allergy Clin Immunol. 2023;152(4):841-857.

18.  Bergantini L, et al. Regulatory T cell monitoring in severe eosinophilic
asthma patients treated with mepolizumab. Scand J Immunol. 2021;94(1):e13031.

 

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