REG - GSK PLC - Nucala COPD submission accepted by US FDA

GSKAnnouncement

09/12/2024 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20241209:nRSI2711Pa&default-theme=true

RNS Number : 2711P  GSK PLC  09 December 2024

Issued: 09 December 2024 London UK

 

US FDA accepts GSK's submission for the use of Nucala (mepolizumab) in COPD

 

·   Submission supported by MATINEE data showing significant and clinically
meaningful reduction in annualised rate of moderate/severe exacerbations
compared with placebo

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

·   COPD affects more than 14 million people in the US with estimates of
500,000 hospitalisations and up to 1.3 million emergency department visits
each year

 

GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration
(FDA) has accepted for review, data from the MATINEE study to support the
regulatory review process to obtain a new indication for the use of Nucala
(mepolizumab), as an add-on maintenance treatment for patients with chronic
obstructive pulmonary disease (COPD) with an eosinophilic phenotype. The
Prescription Drug User Fee Act (PDUFA) date is 7 May 2025.

 

The submission is based on data from the MATINEE study, which evaluated the
efficacy and safety of mepolizumab in 804 patients with COPD who have evidence
of type 2 inflammation characterised by blood eosinophil count.(1) The trial
recruited COPD patients with broad clinical presentations including hard to
treat patients with emphysema-only, chronic bronchitis only, or a mix of both.
The MATINEE study met its primary endpoint with the addition of mepolizumab to
inhaled maintenance therapy, achieving a statistically significant and
clinically meaningful reduction in the annualised rate of moderate/severe
exacerbations versus placebo with patients treated for 52-104 weeks.

 

IL-5 is a key cytokine (protein) in type 2 inflammation, an inflammatory
process exhibited in up to 40% of patients with COPD and the underlying
pathobiology that drives symptoms and exacerbations.(2-4) Type 2 inflammation
is typically detected by blood eosinophil count, a biomarker, which can be
measured by a simple blood test. This test can help indicate a COPD patient's
risk of exacerbation and deterioration, their response to treatment, and
inform treatment strategies in these patients.(5) ( )

 

COPD affects more than 390 million people globally and over 14 million people
in the US, exerting a significant burden on healthcare resources and the lives
of patients.(6-9) Recurrent exacerbations add to pressures on healthcare
systems and account for a large proportion of the annual direct medical costs
of COPD with emergency department visits and inpatient care costing the US
healthcare system around $7 billion a year.(6,8,9)

 

The full results of MATINEE will be presented at a future scientific congress
and form the basis of regulatory submissions around the world.

( )

Nucala is currently approved for use in the US across four IL-5 mediated
conditions. These include two respiratory  indications as an add-on
maintenance treatment for patients with severe asthma with an eosinophilic
phenotype aged 6 years and older and as an add-on maintenance treatment for
adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and
inadequate response to nasal corticosteroids. Indications also include the use
of Nucala for the treatment of adult patients with eosinophilic granulomatosis
with polyangiitis (EGPA) and for the treatment of patients ages 12 years and
older with hypereosinophilic syndrome (HES) for ≥6 months without an
identifiable non-hematologic secondary cause.(12) Nucala is currently not
indicated for COPD anywhere in the world.

 

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

COPD is a progressive and heterogenous inflammatory lung disease that includes
chronic bronchitis and emphysema, and is the third leading cause of death
resulting in more than 3 million deaths annually.(5,7) 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.(5) Exacerbations are acute episodes of
worsening COPD symptoms and can result in hospitalisation and irreversible
lung damage that leads to progressive lung function decline.  Exacerbations
can result in a cycle of deterioration in overall physical health and
increased mortality.(5,12) Many patients experience persistent symptoms and
exacerbations meaning there is a need for targeted therapies to address the
underlying pathophysiology linked to disease progression.(5,13-15)

 

Type 2 inflammation is present in a variety of immuno-inflammatory conditions
and is the underlying pathology that drives symptoms and exacerbations in up
to 40% of people with COPD. (2) Blood eosinophil count is a biomarker for type
2 inflammation that can be easily measured by a simple blood test for levels
of a type of white blood cell called eosinophils. IL-5 is a core cytokine
(protein) in type 2 inflammation alongside IL-4 and IL-13.(2) IL-5 is
responsible for the growth, activity, and survival of eosinophils and there is
now evidence to show IL-5 has broad effects on other immune and structural
cell types beyond eosinophils, including those that contribute to
inflammation, lung remodelling and disease progression.(2,15-20) The
individual role of these cell types has not been definitively established in
COPD.

 

About Nucala

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

 

About the mepolizumab development programme for COPD

The mepolizumab program 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.(21)

 

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

US information available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s004lbl.pdf
(https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s004lbl.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, 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.

 

 GSK enquiries
 Media:               Tim Foley                   +44 (0) 20 8047 5502  (London)
                      Dan Smith / Sarah Clements  +44 (0) 20 8047 5502  (London)
                      Kathleen Quinn              +1 202 603 5003       (Washington DC)
                      Lyndsay Meyer               +1 202 302 4595       (Washington DC)
                      Alison Hunt                 +1 540 742 3391       (Washington DC)

 Investor Relations:  Annabel Brownrigg-Gleeson   +44 (0) 7901 101944   (London)
                      James Dodwell               +44 (0) 20 8047 2406  (London)
                      Mick Readey                 +44 (0) 7990 339653   (London)
                      Camilla Campbell            +44 (0) 7803 050238   (London)
                      Steph Mountifield           +44 (0) 7796 707505   (London)
                      Jeff McLaughlin             +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco            +1 215 751 4855       (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 under
Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSK's Q3 Results for 2024.

 

Registered in England & Wales:

No. 3888792

Registered Office:

79 New Oxford Street

London

WC1A 1DG

 

References

1.   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%20Last%20accessed%20%20October%202024)
. Last accessed November 2024.

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.   GOLD Science Committee Members (2023-2024). The Global Strategy for
Diagnosis, Management and Prevention of CO 2024. Available at:
www.goldcopd.org (http://www.goldcopd.org) Last accessed: November 2024.

6.   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.

7.   Boers E, et al. Global Burden of Chronic Obstructive Pulmonary Disease
Through 2050. JAMA Netw Open. 2023;6(12).

8.   CDC. Trends in the Prevalence of Chronic Obstructive Pulmonary Disease
Among Adults Aged ≥18 Years - United States, 2011-2021. Weekly / November
17, 2023 / 72(46);1250-1256. Available at; Trends in the Prevalence of Chronic
Obstructive Pulmonary Disease Among Adults Aged ≥18 Years - United States,
2011-2021 | MMWR (cdc.gov)
(https://www.cdc.gov/mmwr/volumes/72/wr/mm7246a1.htm#:~:text=From%202011%20to%202021,%20prevalence%20of%20COPD%20among%20adults%20remained)
Last accessed: November 2024.

9.   American Lung Association. COPD Trends Brief - Burden. Available at:
https://www.lung.org/research/trends-in-lung-disease/copd-trends-brief/copd-burden
(https://www.lung.org/research/trends-in-lung-disease/copd-trends-brief/copd-burden)
Last accessed: November 2024.

10.  Press VG, et al. Preventing COPD Readmissions Under the Hospital
Readmissions Reduction Program: How Far Have We Come? Chest.
2021;159(3):996-1006.

11.  Ruan, H,  et al. Readmission rate for acute exacerbation of chronic
obstructive pulmonary disease: A systematic review and meta-analysis. Respir.
Med. 2023, 206, 107090.

12.  U.S. Food and Drug Administration. Nucala Full Prescribing Information.
Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf
(http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf) .
Last accessed November 2024.

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

14.  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.

15.  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.

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

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

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

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

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

21.  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.

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCEAEAPESLLFAA