Issued: 28
August 2024, London UK
GSK's Nucala (mepolizumab) approved
in Japan for treatment of adults with
chronic rhinosinusitis with nasal polyps
· Nucala
is the first and only biologic in Japan with a
four-weekly dosing schedule for this condition
· Chronic rhinosinusitis with nasal polyps (CRSwNP) exerts
significant physical and emotional burden on patients with surgery
often the only option
· This
is the third indication for Nucala in Japan for an IL-5 mediated
condition
GSK plc (LSE/NYSE: GSK) today
announced that Japan's Ministry of Health, Labour
and Welfare (MHLW) has approved Nucala (mepolizumab),
a monoclonal antibody that targets
interleukin-5 (IL-5), for
the treatment of chronic rhinosinusitis
with nasal polyps (CRSwNP) in adult patients, limited to those who
are inadequately controlled with standard treatment.
Kaivan
Khavandi, SVP, Global Head of Respiratory/Immunology R&D, at
GSK said: "The chronic
and debilitating impact that chronic rhinosinusitis with nasal
polyps can have on those affected is often
underestimated.
This additional indication for Nucala in Japan could provide patients with an
alternative treatment option to surgery or systemic
steroids."
CRSwNP is
a chronic condition that affects
1% to 4% of the general population, of whom 40%
have uncontrolled disease.1,2 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.3
In Japan, an
estimated 2 million people suffer from chronic
rhinosinusitis, of which about 200,000 are subject to surgery due
to nasal polyps.4
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.3 Over 80% of
patients with CRSwNP have type 2 inflammation, which is
associated with more severe disease and nasal polyp
recurrence.5-8 IL-5 is a key cytokine driving this type
2 inflammation and is present at high levels in nasal polyp
tissue.3,5-8 Although surgery
can be effective at removing polyps, the underlying type 2
inflammation means they have a tendency to
regrow.7,8
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 in a population of Japanese, Chinese and
Russian patients with inadequately controlled CRSwNP,
supported by data from the global phase III
SYNAPSE study, which explored the effect of mepolizumab vs. placebo
in more than 400 patients with CRSwNP.3,9
Mepolizumab
is approved in Japan as a treatment for bronchial
asthma in children aged 6 years or older and in adults with
refractory asthma whose symptoms are inadequately controlled with
standard treatment, and also for the treatment of adult patients
with eosinophilic granulomatosis with polyangiitis (EGPA)
inadequately responding to the standard treatment.
About the MERIT trial9
The phase III MERIT trial 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.1 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. Safety and
tolerability data were consistent with the known profile of
mepolizumab.3,5 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 AEs (five in the placebo group and two in the
mepolizumab group); none of these were SAEs.
About Nucala
(mepolizumab)
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.10,11 IL-5 is
central to the development, maturation and activation of
eosinophils, a type of white blood cell implicated in the
pathogenesis of asthma and CRSwNP.3 Evidence indicates
that IL-5 has an impact on other cell types beyond eosinophils that
contribute to inflammation in airways
disease.12-16 Mepolizumab binds
directly to and inhibits IL-5 molecules.10,11 Mepolizumab has been
developed for the treatment of a range of IL-5 mediated diseases
associated with type 2 inflammation.10,11
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)
|
|
Sarah Clements
|
+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 GSK's
Annual Report on Form 20-F for 2023, and GSK's Q2 Results for
2024.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
References
1. 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.
2. van der Veen J,
et al. Real-life study showing uncontrolled rhinosinusitis after
sinus surgery in a tertiary referral centre. Allergy.
2017;72(2):282-290.
3. Han JK, et al.
Mepolizumab for chronic rhinosinusitis with nasal
polyps (SYNAPSE): a randomised, double-blind, placebo-controlled,
phase 3 trial. The Lancet
Respiratory Medicine.
2021;9(10):1141-1153.
4. JESREC
Study About refractory
eosinophilic sinusitis available
at
https://jesrec.jp/general/disease.html. Last accessed September
2023.
5. Kato A, et al.
Endotypes of chronic rhinosinusitis: Relationships to disease
phenotypes, pathogenesis, clinical findings, and treatment
approaches. Allergy.
2022;77(3):812-826.
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. 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(Suppl. 1):S3-S13.
8. 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.
9. Fujieda S,
et al. Mepolizumab in
CRSwNP/ECRS and NP: The Phase III randomised MERIT trial in Japan,
China and Russia. Rhinology (2024)
10. U.S. Food and Drug
Administration. Nucala Full Prescribing Information. Available
at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf.
Last accessed December 2023.
11. European summary of
product characteristics available at
https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf
last accessed February 2023
12. Buchheit KM, et al.
Mepolizumab targets multiple immune cells in aspirin-exacerbated
respiratory disease. J Allergy
Clin Immunol. 2021;148(2):574-584.
13. Barretto KT, et al. Human
airway epithelial cells express a functional IL-5 receptor.
Allergy.
2020;75(8):2127-2130.
14. Bajbouj K, et al. IL-5
receptor expression in lung fibroblasts: Potential role in airway
remodelling in asthma. Allergy.
2023;78(3):882-885.
15. Siddiqui S, et al.
Eosinophils and tissue remodelling: Relevance to airway disease.
J Allergy Clin Immunol.
2023;152(4):841-857.
16. Bergantini L, et al.
Regulatory T cell monitoring in severe eosinophilic asthma patients
treated with mepolizumab. Scand J
Immunol. 2021;94(1):e13031.