REG - GSK PLC - Nucala approved in China for use in severe asthma

GSKAnnouncement

10/01/2024 07:00

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RNS Number : 1386Z  GSK PLC  10 January 2024

Issued: 10 January 2024, London UK

 

Nucala (mepolizumab) approved in China for use in severe asthma with an
eosinophilic phenotype

 

·   Mepolizumab is the first targeted anti-Interleukin-5 (IL-5) biologic
available in China as an add-on maintenance treatment for severe eosinophilic
asthma

·   Asthma is a major health priority in China with millions affected by
severe disease

·   Approval based on a separate phase III trial among Chinese patients
reinforcing mepolizumab's efficacy and safety data

 

 

 

GSK plc (LSE/NYSE: GSK) today announced that the China National Medical
Products Administration has approved Nucala (mepolizumab) as an add-on
maintenance treatment for severe eosinophilic asthma in adults and adolescents
aged 12 years and older. Nucala is the first anti-Interleukin-5 (IL-5)
targeting treatment approved for use in China for adult and adolescent
patients with this condition.

 

Asthma is a major health burden in China affecting an estimated 46 million
adults.(1) Of those, approximately 6% experience severe asthma, which confers
the most substantial impact on daily living, is associated with an increased
risk of exacerbations requiring hospitalisation, and higher likelihood of
potentially fatal asthma attacks.(1-5) In China, 15.5% of people with asthma
have experienced an exacerbation requiring a hospital visit in the preceding
12 months.(1)

 

Kaivan Khavandi, Senior Vice President, Global Head, Respiratory and
Immunology, R&D, said: "We are delighted with this approval, supported by
evidence in a Chinese population. Millions of people in China with severe
eosinophilic asthma can now potentially benefit from the advance in management
that Nucala could offer - a testament to GSK's ongoing commitment to redefine
respiratory disease management globally."

 

Guidelines for bronchial asthma prevention and management (2020 edition) from
the Asthma group of the Chinese Thoracic Society reference the current unmet
need among Chinese patients with this condition.(6) The guidelines also
reference evidence for targeted biologic therapy that could reduce
exacerbations, emergency or hospitalisation rates, oral corticosteroid use,
and also improve asthma control and lung function.(6)

 

The approval for use in severe asthma is based on positive data from a
separate phase III trial among Chinese patients.(7,8) The results from the
Chinese study reinforce existing data for mepolizumab in patients with severe
asthma.(8-13) Adverse events were consistent with the known safety profile for
mepolizumab with no new emerging safety issues specific to Chinese patients.
(8-13) The global clinical development programme included four key clinical
trials - DREAM(9), MENSA(10), SIRIUS(11) and MUSCA.(12) These trials
established the efficacy and safety profile of mepolizumab in patients with
severe asthma with an eosinophilic phenotype with safety data coming from
pivotal, long-term and real-world studies.(9-14)

 

The 52-week phase III trial in Chinese patients with severe asthma studied the
effect of mepolizumab relative to placebo, as add-on on the primary endpoint
of reduction in the annual rate of clinically significant exacerbations
(CSE).(7,8) Patients in the trial who received mepolizumab compared to those
who received placebo experienced 65% fewer CSE's (0.45 vs.1.31 events/year, HR
[95% CI]: 0.35 [0.24, 0.50] p<0.001), had a 70% reduction in the frequency
of CSE per year requiring hospitalisation or Emergency Department (ED) visits
(RR [95% CI] 0.30  0.12,0.77 ; p=0.012), and a significantly increased period
of time before patients experienced the first CSE requiring hospitalisation or
ED visits (3.4% vs. 12.6%; HR [95% CI]: 0.26 [0.10, 0.69]; p=0.007).(8)

 

This is the second indication for mepolizumab in China, with approval for use
in adults with eosinophilic granulomatosis with polyangiitis (EGPA) received
in 2021. Epidemiological, clinical and pathophysiological studies show that
patients with EGPA usually also have asthma, which is often severe.(15)

 

About Nucala (mepolizumab)

First approved in 2015 for severe asthma with an eosinophilic phenotype in the
US, Nucala is the first-in-class monoclonal antibody to target IL-5.(16,17)
Mepolizumab as the first anti-IL-5 targeting biologic approved in China is an
important medical advance in the management of asthma. IL-5 is an inflammatory
signalling molecule that is central to the development, maturation and
activation of eosinophils, a type of white blood cell implicated in the
pathogenesis in the majority of cases of severe asthma.(18) Evolving evidence
suggests IL-5 has an impact on other cell types beyond eosinophils, leading to
epithelial barrier dysfunction, airways remodelling and disease
progression.(19-25) Mepolizumab binds directly to and inhibits IL-5
molecules.(16,17)

( )

Nucala is currently approved in China for use in adults with EGPA and was
included on the National Reimbursement Drug List in January 2023. Nucala has
been studied in over 4,000 patients in 41 clinical trials across several IL-5
mediated conditions and was the first treatment approved in the US and Europe,
across four IL-5 medicated conditions: severe asthma with an eosinophilic
phenotype, EGPA, hypereosinophilic syndrome and chronic rhinosinusitis with
nasal polyps.(16,17) Nucala has been approved in the US, the European Union
and over 25 other markets as an add-on maintenance treatment for patients with
severe asthma.

 

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

 

EU and UK available at:

https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf

 

US available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf
(http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf)

 

About severe asthma

Severe asthma is defined as asthma which requires treatment with high-dose
inhaled corticosteroids plus a second controller (and/or systemic
corticosteroids) to prevent it from becoming 'uncontrolled' or which remains
'uncontrolled' despite this therapy.(8-11) Severe asthma patients can also be
categorised by long-term oral corticosteroid use. In a sub-set of severe
asthma patients, type two inflammation and over-production of eosinophils (a
type of white blood cell) leads to a range of symptoms and longer-term lung
remodelling.(8-11) The majority (more than 80%) of severe asthma patients
exhibit elevated levels of eosinophils, which act as bio-marker to facilitate
diagnosis, predict risk of exacerbations and aid evidence-based treatment
decisions.(26)

 

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 the company's Annual Report on Form 20-F for 2022,
and Q3 Results for 2023.

 

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References

1.    Huang K, Yang T, Xu J, et al. Prevalence, risk factors, and
management of asthma in China: a national cross-sectional
study. Lancet. 2019; 394:407-418.

2.    Ding B, Small M, Wang W, et al. The disease burden of mild asthmatics
in China. European Respiratory Journal. 2016; 48 (suppl 60): PA4208

3.    National Heart, Lung, and Blood Institute. Guidelines for the
Diagnosis and Management of Asthma (EPR-3).  Online . Available at:
https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma
(https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma)
. [Accessed January 2024.]

4.    Ambrosino, N and Paggiaro, P. The management of asthma and chronic
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5.    Antonicelli, L, Bucca C, Neri M, et al. Asthma severity and medical
resource utilisation. Eur Respir J. 2004;23(5):723-729.

6.    A Safety and Efficacy Study of Mepolizumab in Subjects With Severe
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in Subjects With Severe Asthma - Full Text View - ClinicalTrials.gov
(https://clinicaltrials.gov/ct2/show/NCT03562195) last accessed December 2023.

7.    Asthma Group of the Chinese Thoracis Society. Guidelines for
bronchial asthma prevent and management(2020 edition) Asthma group of Chinese
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Respiration,2020,43(12):1023-1048. Available at:
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(China Asthma Guideline 2020
支气管哮喘防治指南(2020年版). 中华结核和呼吸杂志, 43(12),
26.)

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Add-On Therapy in Chinese Patients With Severe Eosinophilic Asthma: A
Randomized, Double-Blind, Parallel Group Phase 3 Study. Poster P620 presented
at Presented at the American Thoracic Society Meeting, Washington, DC, May
19-24, 2023. Available at:
https://presentations.gsk.com/wp-content/uploads/2023/03/ATS_QR14_Chen.pdf
(https://presentations.gsk.com/wp-content/uploads/2023/03/ATS_QR14_Chen.pdf)
last accessed December 2023.

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eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled
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with Severe Eosinophilic Asthma. N Engl J Med. 2014;371(13):1198-1207.

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Effect of Mepolizumab in Eosinophilic Asthma. N Engl J Med.
2014;371(130:1189-1197.

12.  Chupp GL, Bradford ES, Albers FC, et al. Efficacy of mepolizumab add-on
therapy on health-related quality of life and markers of asthma control in
severe eosinophilic asthma (MUSCA): a randomised, double-blind,
placebo-controlled, parallel group, multicentre, phase 3b trial. Lancet Respir
Med. 2017;5(5):390-400.

13.  Flood-Page P, Swenson C, Faiferman I, et al. A study to evaluate safety
and efficacy of mepolizumab in patients with moderate persistent asthma. Am J
Respir Crit Care Med. 2007;176(11):1062-1071.

14.  Unpublished abstract - GSK data on file (Pavord, et al. Abstract 201956
presented at ERS 2023).

15.  Porsbjerg C, Menzies-Gow A. Co-morbidities in severe asthma: Clinical
impact and management. Respirology. 2017;22(4):651-661. doi:10.1111/resp.13026

16.  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 December 2023

17.  European summary of product characteristics available at
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last accessed February 2023
(https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf%20last%20accessed%20February%202023)

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other airway diseases. ERJ Open Res. 2022;8(3):00576-2021.

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severe asthma. Allergy. 2022;77(12):3538-3552.

24.  Santini G, Mores N, Malerba M, et al. Dupilumab for the treatment of
asthma. Expert Opin Investig Drugs. 2017;26(3);357-366.

25.  Israel E and Reddel HK. Severe and Difficult-to-Treat Asthma in Adults.
N Engl J Med. 2017;377(10):965-976.

26.  Heaney LG, Perez de Llano L, Al-Ahmad M, et al. Eosinophilic and
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2021;160(3):814-830.

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