REG - GSK PLC - Nucala NDA accepted for review in China

GSKAnnouncement

14/03/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230314:nRSN8237Sa&default-theme=true

RNS Number : 8237S  GSK PLC  14 March 2023

Issued: 14 March 2023, London UK

 

China National Medical Products Administration accepts regulatory submission
for Nucala (mepolizumab) in severe eosinophilic asthma

 

 

GSK plc (LSE/NYSE: GSK) today announced that the China National Medical
Products Administration has accepted for review a new drug application for
Nucala (mepolizumab) as an add-on maintenance treatment for severe
eosinophilic asthma (SEA). If approved, Nucala would be the first targeted
anti-Interleukin-5 (IL-5) treatment in China for adult and adolescent patients
with this condition.

 

The application is based on positive data from a phase III trial among Chinese
patients(1) and the global SEA development programme, which included three key
clinical trials - DREAM(2), MENSA(3) and SIRIUS(4) - that established the
efficacy and safety profile of mepolizumab for severe eosinophilic asthma
patients. The 52-week phase III trial in Chinese patients studied the effect
of mepolizumab as adjunctive therapy in patients with SEA with a primary
endpoint of reduction, relative to placebo, in the annual rate of clinically
significant exacerbations.(1) The efficacy and safety of mepolizumab in the
Chinese population were shown to be consistent with that in a non-Chinese
population with SEA.(2-5)

 

Asthma affects an estimated 46 million adults in China, with 6% experiencing
severe asthma.(6-8)

Patients with SEA have an increased risk of exacerbations requiring
hospitalisation or an increased likelihood of a potentially fatal asthma
attack.(9,10) 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 SEA.(11)

Nucala is currently approved in China for use in adults with eosinophilic
granulomatosis with polyangiitis (EGPA) and was included on the National
Reimbursement Drug List in January 2023. However, Nucala is not currently
approved in China for the treatment of SEA.

 

About Nucala (mepolizumab)

First approved in 2015 for SEA in the US, Nucala is the first-in-class
monoclonal antibody to target IL-5. It is believed to work by preventing IL-5
from binding to its receptor on the surface of eosinophils, reducing blood
eosinophils and maintaining them within normal levels.(12)

Nucala has been studied in over 4,000 patients in 41 clinical trials across
several eosinophilic indications and was the first treatment approved in the
US across four eosinophil-driven diseases: SEA, EGPA, hypereosinophilic
syndrome and chronic rhinosinusitis with nasal polyps. Nucala has been
approved in the US, the European Union and over 25 other markets as an add-on
maintenance treatment for patients with SEA.

About severe eosinophilic 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.(2-5) Severe asthma patients can also be
categorised by long-term oral corticosteroid use. In a sub-set of severe
asthma patients, the over-production of eosinophils (a type of white blood
cell) is known to cause inflammation in the lungs; this is known as SEA.(2-5)
IL-5 is the leading promoter of eosinophil growth, activation and survival and
provides an essential signal for the movement of eosinophils from the bone
marrow into the lung. The majority (up to 80%) of severe asthma patients are
eosinophilic, according to a real-world observational study(13).

 

 

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/company
(https://www.gsk.com/en-gb/company/)

 

 

 GSK enquiries
 Media:               Tim Foley             +44 (0) 20 8047 5502      (London)
                      Dan Smith             +44 (0) 20 8047 5502      (London)
                      Kathleen Quinn        +1 202 603 5003           (Washington DC)
                      Lyndsay Meyer         +1 202 302 4595           (Washington DC)

 Investor Relations:  Nick Stone            +44 (0) 7717 618834       (London)
                      James Dodwell         +44 (0) 20 8047 2406      (London)
                      Mick Readey           +44 (0) 7990 339653       (London)
                      Josh Williams         +44 (0) 7385 415719       (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 the company's Annual Report on Form 20-F for 2022,
GSK's Q4 Results for 2022 and any impacts of the COVID-19 pandemic.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

 

References

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

2.    Pavord, I. D. et al. Mepolizumab for severe eosinophilic asthma
(DREAM): a multicentre, double-blind, placebo-controlled trial. The Lancet.
2012. 380, ISSUE (9842) 651-659

3.    Ortega, H.G et al Mepolizumab Treatment in Patients with Severe
Eosinophilic Asthma. N Engl J Med 2014; 371:1198-1207

4.    Bell, E.H. et al. Oral Glucocorticoid-Sparing Effect of Mepolizumab
in Eosinophilic Asthma. N Engl J Med 2014; 371:1189-1197. DOI:
10.1056/NEJMoa1403291

5.    Chupp GL, 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. Su N, et.
al. Chin J Intern Med.2016, 55(12):917-921.

6.    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.

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

8.    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.
[Accessed February 2023]

9.    Ambrosino, N and Paggiaro, P. The management of asthma and chronic
obstructive pulmonary disease: current status and future perspectives Expert
Rev. Respir. Med. 6(1), 117-127 (2012)2012;

10.  Antonicelli, L et al. Asthma severity and medical resource utilisation.
Eur Respir J 2004; 23: 723-729

11.  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

12.  European summary of product characteristics 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 February 2023

13.  Azim A, et al. Clinical evaluation of type 2 disease status in a
real-world population of difficult to manage asthma using historic electronic
healthcare records of blood eosinophil counts. Clin Exp Allergy. 2021
Jun;51(6):811-820.

 

 

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  MSCDXGDXDBBDGXX