REG - GSK PLC - FDA approves Nucala COPD indication

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RNS Number : 8768J  GSK PLC  23 May 2025

Issued: 22 May 2025, London UK

 

Nucala (mepolizumab) approved by US FDA for use in adults with chronic
obstructive pulmonary disease (COPD)

 

·   Nucala is the only approved biologic studied in a wide COPD population
with an eosinophilic phenotype characterised by blood eosinophil count (BEC)
starting at 150 cells/μL

·   Approval based on the positive MATINEE and METREX phase III trials

·   MATINEE data included reduction of exacerbations leading to
hospitalisation and/or emergency department visits

·   Nearly 70% of patients in the US who are inadequately controlled on
inhaled triple therapy have a BEC ≥150 cells/μL

 

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved Nucala (mepolizumab) as an add-on
maintenance treatment for adult patients with inadequately controlled COPD and
an eosinophilic phenotype.

 

FDA's approval was based on data from the positive MATINEE and METREX phase
III trials. Across these trials, mepolizumab showed a clinically meaningful
and statistically significant reduction in the annualised rate of
moderate/severe exacerbations versus placebo in a wide spectrum of COPD
patients with an eosinophilic phenotype.(1,2) Preventing exacerbations is a
key goal of COPD management.(3) Exacerbations are devastating for patients,
known to cause irreversible lung damage, worsening of symptoms and increased
mortality.(3) The incidence of adverse events was similar between placebo and
mepolizumab groups.(1,2)

 

Mepolizumab is the only approved biologic evaluated in patients with an
eosinophilic phenotype characterised by a blood eosinophil count (BEC)
threshold as low as ≥150 cells/µL.(1,2) BEC is captured by a simple blood
test that measures levels of eosinophils, a type of white blood cell which is
a biomarker for type 2 inflammation and indicates a patient's risk of
exacerbation.(3) Approximately 70% of COPD patients in the US who are
inadequately controlled on inhaled triple therapy and continue to exacerbate
have a BEC starting at 150 cells/μL and above.(4,5) This represents over a
million people at risk of exacerbations, including those leading to emergency
department (ED) visits and/or hospitalisations, who could add mepolizumab as
an option to their COPD treatment.(4,5)

 

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation
R&D, GSK, said: "The approval of Nucala in the US provides an important
option for COPD patients. Long-term follow-up studies have demonstrated that
exacerbations are the single most important predictor of future risk, with
particularly poor outcomes in those requiring hospital visits or admissions.
Today there is hope for improved care for COPD patients with an eosinophilic
phenotype, including those with a BEC threshold as low as ≥150cells/μL who
need new options like Nucala to support their treatment journey."

 

Jean Wright, MD, MBA, Chief Executive Officer of the COPD Foundation said:
"COPD isn't just a disease, it's a relentless cycle. For individuals living
with COPD, managing exacerbations is an ongoing challenge, even with inhaled
maintenance therapy. Biologics like mepolizumab are providing renewed
optimism for those affected by COPD."

 

In both MATINEE and METREX trials, mepolizumab demonstrated a statistically
significant reduction in the annualised rate of moderate or severe
exacerbations compared with placebo, in patients with an eosinophilic
phenotype, when added to triple inhaled therapy (MATINEE: rate ratio  RR ,
0.79; 95% confidence interval  CI , 0.66 to 0.94; p=0.01) (METREX: rate ratio,
0.82; 95% CI, 0.68 to 0.98; adjusted p=0.04).(1,2) In a pre-defined secondary
endpoint in MATINEE, the annualised rate of COPD exacerbations requiring ED
visits and/or hospitalisation was reduced in the mepolizumab group when
compared with placebo (rate ratio  RR  of 0.65; 95% CI: 0.43, 0.96 [not
statistically significant due to a failure of an endpoint higher in the
pre-defined testing hierarchy]).(1) COPD-related hospitalisations are a major
healthcare challenge and are projected to become the number one cause of
medical admissions.(6) Emergency department visits and inpatient care already
account for a large proportion of the annual direct medical costs of COPD,
costing the US healthcare system around $7 billion a year.(7)

 

Mepolizumab is currently not approved for use in COPD in any other country.
Regulatory submissions are under review in China and Europe.

 

About MATINEE and METREX

 

Both MATINEE and METREX are phase III, randomised (1:1), double-blind,
parallel-group trials 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).(1,2)

 

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 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.(1)

 

The full study results from MATINEE were recently published in the New England
Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2413181) (1)
with further data presented at the 2025 American Thoracic Society
International Congress, including additional sub-analyses in patients with or
without cardiovascular comorbidities, varying severities of prior
exacerbations, and those with chronic bronchitis, emphysema-only or both.(1)

 

In METREX, the efficacy and safety of mepolizumab was evaluated for 52 weeks
in 836 patients randomised (1:1) to mepolizumab or placebo across two groups,
the eosinophilic phenotype group (blood eosinophil count of ≥150 cells/µl
at study entry or ≥ 300 cells/µl within the past year) or the
non-eosinophilic phenotype group (blood eosinophil count of <150 cells/µl
at study entry and no evidence of ≥300 cells/µl within the past year).

The study results from METREX were published in 2017 in the New England
Journal of Medicine.(2)

 

About COPD

COPD is a progressive and heterogeneous inflammatory lung disease that
includes chronic bronchitis and/or emphysema.(3) It affects more than 390
million people globally and is the third leading cause of death.(8,9) 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.(3)

 

Despite inhaled triple therapy, many patients experience persistent symptoms
and exacerbations.(10) Exacerbations are acute episodes of worsening COPD
symptoms, which can result in hospitalisation and irreversible lung
damage.(3) Early intervention is important in preventing exacerbations and
cumulative lung damage.(3)

 

About Nucala

Nucala is a monoclonal antibody that targets and binds to interleukin-5
(IL-5), a key messenger protein (cytokine) in type 2 inflammation. Nucala has
been developed for the treatment of a range of IL-5 mediated diseases
associated with type 2 inflammation. It is currently approved for use in
Europe across four IL-5 mediated conditions and in the US across five such
conditions.

 

The US Prescribing Information is available at NUCALA-PI-PIL-IFU-COMBINED.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF)
(11)

 

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.

 

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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 Q1 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/full/10.1056/NEJMoa2413181
(https://www.nejm.org/doi/full/10.1056/NEJMoa2413181) . Last accessed May 2025

2.     Pavord ID, et al. Mepolizumab for Eosinophilic Chronic Obstructive
Pulmonary Disease. N Engl J Med. Oct 2017;377:1613-1629. DOI:
10.1056/NEJMoa1708208 (https://www.nejm.org/doi/full/10.1056/NEJMoa1708208) .

3.     Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2025
Gold Report. Available at: goldcopd.org
(https://goldcopd.org/2025-gold-report/) . Last accessed May 2025.

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

5.     Müllerová H, et al. Exacerbations and health care resource use
among patients with COPD in relation to blood eosinophil counts. Int J Chron
Obstruct Pulmon Dis. 2019;14:683-692. DOI: 10.2147/COPD.S194367
(https://doi.org/10.2147/COPD.S194367) .

6.     Khakban A, et al. The Projected Epidemic of Chronic Obstructive
Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based
Perspective. Am J Respir Crit Care Med. 2017;195(3):287-291. DOI:
10.1164/rccm.201606-1162PP
(https://www.atsjournals.org/doi/10.1164/rccm.201606-1162PP?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed)
.

7.     American Lung Association (ALA). COPD Trends Brief - Burden.
Available at: Lung.org
(https://www.lung.org/research/trends-in-lung-disease/copd-trends-brief/copd-burden)
. Last accessed: May 2025.

8.     Adeloye D, et al. 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;10(5):447-458. DOI: 10.1016/S2213-2600(21)00511-7
(https://doi.org/10.1016/s2213-2600(21)00511-7) .

9.     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.
(https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00511-7/fulltext)

10.    Chen S, Miravitlles M, Rhee CK, et al. Patients with Chronic
Obstructive Pulmonary Disease and Evidence of Eosinophilic Inflammation
Experience Exacerbations Despite Receiving Maximal Inhaled Maintenance
Therapy. Int J Chron Obstruct Pulmon Dis. 2022 Sep 9;17:2187-2200. DOI:
10.2147/COPD.S378649 (https://doi.org/10.2147/copd.s378649) .

1.     Food and Drug Administration. Nucala Full Prescribing Information.
Available
at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF)

 

 

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