REG - GSK PLC - GSK’s Nucala approved in China for use in CRSwNP

GSKAnnouncement

03/01/2025 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:20250103:nRSC9776Ra&default-theme=true

RNS Number : 9776R  GSK PLC  03 January 2025

Issued: 3 January 2025, London UK

 

GSK's Nucala (mepolizumab) approved in China for treatment of adults with
chronic rhinosinusitis with nasal polyps

 

·  Mepolizumab is the only anti-interleukin-5 approved in China for the
treatment of adults with inadequately controlled chronic rhinosinusitis with
nasal polyps (CRSwNP)

·  Around 30 million people in China live with CRSwNP and experience
symptoms such as sleep disturbance, breathing problems and loss of smell

·  This is the third indication for mepolizumab in China for an IL-5
mediated condition

 

GSK plc (LSE/NYSE: GSK) today announced that the China National Medical
Products Administration has approved Nucala (mepolizumab), a monoclonal
antibody that targets interleukin-5 (IL-5), as an add-on therapy with
intranasal corticosteroids for the treatment of adult patients with CRSwNP for
whom therapy with systemic corticosteroids and/or surgery do not provide
adequate disease control.

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D at
GSK said: "We are delighted that Nucala has been approved in China as a
treatment for CRSwNP, a chronic condition for which new and effective
treatments are needed. Patients now have a non-surgical option available to
them and an alternative to repeated exposure to oral corticosteroids."

It is estimated that about 107 million people in China suffer from chronic
sinusitis, about 1/3 of whom have chronic sinusitis with nasal polyps.(1-4)
People with CRSwNP experience symptoms such as nasal obstruction, loss of
smell, facial pressure, sleep disturbance and nasal discharge, which can
significantly affect their emotional and physical well-being.(4-6)

CRSwNP is caused by chronic inflammation of the nasal lining that can cause
soft tissue growth, known as nasal polyps, that develop in the sinuses and
nasal cavity.(5,6) Up to 80% of patients with CRSwNP have type 2
inflammation, which is associated with more severe disease and nasal polyp
recurrence and can be detected by blood eosinophil count, a biomarker measured
by a simple blood test.(6-9) IL-5 is a key cytokine driving this type 2
inflammation and is present at high levels in nasal polyp tissue.(4-8)
Although surgery can be effective at removing polyps, the underlying type 2
inflammation means they have a tendency to regrow.(9,10)

The approval is based on results of the phase III MERIT trial, which studied
the efficacy and safety of mepolizumab over a 52-week period versus placebo in
a population of Japanese, Chinese and Russian patients with inadequately
controlled CRSwNP, and is supported by data from the global phase III SYNAPSE
study, which explored the effect of mepolizumab versus placebo in more than
400 patients with CRSwNP.(5,10)

Mepolizumab is already approved in China as an add-on maintenance treatment
for adults and adolescents aged 12 years and older with severe eosinophilic
asthma as well as for adults with eosinophilic granulomatosis with
polyangiitis.

 

About the MERIT trial(10)

The MERIT trial was a randomised, double-blind, placebo-controlled,
parallel-group, 52-week Phase III study to assess the efficacy and safety of
mepolizumab in patients with chronic rhinosinusitis with nasal polyps
(CRSwNP)/eosinophilic CRS (ECRS) in Japan, Russia, and China. The co-primary
endpoints were change from baseline in nasal obstruction visual analogue scale
(VAS) score during weeks 49 to 52 compared with placebo and change in
endoscopic nasal polyp score at week 52 compared with placebo. Results from
163 participants (mepolizumab =80, placebo = 83) showed that treatment with
mepolizumab significantly improved nasal obstruction VAS score (mean treatment
difference: -1.43 [95% CI: -2.37, -0.50]; p=0.003) and was associated with a
numerical reduction in nasal polyp score at week 52 (-0.43 [-0.89, 0.03];
p=0.067). Improvements in patient quality of life, as measured by the 22-item
Sino-Nasal Outcome Test (SNOT-22) were demonstrated with mepolizumab versus
placebo at Week 52 (difference: -10.63 [-18.68, -2.57]; p=0.01 and loss of
smell VAS score at Weeks 49-52 (difference: -0.82 [-1.43, -0.21]; p=0.009).
Safety and tolerability data were consistent with the known profile of
mepolizumab.(4,9-11) A similar proportion of patients experienced on-treatment
adverse events in the mepolizumab (68/84  81% ) and placebo (65/85  76% )
groups. In total, seven patients had treatment-related adverse events (five in
the placebo group and two in the mepolizumab group); none of these were severe
adverse events.

 

About Nucala (mepolizumab)

First approved in 2015 for severe asthma with an eosinophilic phenotype in the
US, mepolizumab is a monoclonal antibody that binds directly to and inhibits
interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2
inflammation.(11,12) Mepolizumab has been developed for the treatment of a
range of IL-5 mediated diseases associated with type 2 inflammation.(10,11)

 

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

 

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.    Liu Z, et al. Chinese Society of Allergy and Chinese Society of
Otorhinolaryngology-Head and Neck Surgery Guideline for Chronic
Rhinosinusitis. Allergy Asthma Immunol Res. 2020;12(2):176-237.

2.    Wu Q, et al. Efficacy and safety of omalizumab in chronic
rhinosinusitis with nasal polyps: a systematic review and meta-analysis of
randomised controlled trials. BMJ Open. 2021 Sep;11(9):e047344.

3.    Bachert C, et al. Burden of Disease in Chronic Rhinosinusitis with
Nasal Polyps. J Asthma Allergy. 2021;14:127-134.

4.    Wang Chengshuo, Zhang Luo. Biologics for the treatment of chronic
rhinosinusitis with nasal polyps  J  . Chinese Journal of Otolaryngology-Head
and Neck Surgery, 2023, 58(3) : 193-199.

5.    Han JK, et al. Mepolizumab for chronic rhinosinusitis with nasal
polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3
trial. Lancet Respir Med. 2021;9(10):1141-1153.

6.    Bachert C, et al. EUFOREA expert board meeting on uncontrolled severe
chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions
and management. J Allergy Clin Immunol. 2021;147(1):29-36.

7.    Kato A, et al. Endotypes of chronic rhinosinusitis: Relationships to
disease phenotypes, pathogenesis, clinical findings, and treatment approaches.
Allergy. 2022;77(3):812-826.

8.    De Corso E, et al. How to manage recurrences after surgery in CRSwNP
patients in the biologic era: a narrative review. Acta Otorhinolaryngol Ital.
2023;43(2 Suppl. 1):S3-S13.

9.    Chen S, et al. Systematic literature review of the epidemiology and
clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med Res
Opin. 2020;36(11):1897-1911.

10.  Fujieda S, et al. Mepolizumab in CRSwNP/ECRS and NP: The Phase III
randomised MERIT trial in Japan, China and Russia. Rhinology.  26 July
2024.   doi: 10.4193/Rhin24.156. Online ahead of print.

11.  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 October 2024

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%20last%20accessed%20February%202023)
  Last accessed December 2024

 

 

 

 

 

 

 

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  REAELLFBEFLEBBV