# GSK’s Nucala accepted for review as a sJNDA in Japan

- Link: https://www.directorstalkinterviews.com/gsks-nucala-accepted-for-review-as-a-sjnda-in-japan/4121126455
- Published: 2023-09-01T07:31:00+01:00
- Author: Amilia Stone

**[GSK plc](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l)**(
LON/NYSE:GSK) has announced that the Japanese Ministry of Health, Labour and Welfare(
MHLW) has accepted for review a supplementary new drug application (sJNDA) for _Nucala_(
mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment
for chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients.

·  If approved, _Nucala_ would be the first anti-interleukin-5 biologic available
in Japan for the treatment of adults with inadequately controlled chronic rhinosinusitis
with nasal polyps (CRSwNP)

·  This would be the third indication for mepolizumab in Japan for an IL-5 mediated
condition

The sJNDA is based on results of the pivotal 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 or eosinophilic
chronic rhinosinusitis (ECRS) as well as data from the global phase III SYNAPSE 
study, which explored the effect of mepolizumab vs. placebo in more than 400 patients
with CRSwNP.^(1,2)

CRSwNP/ECRS affects 2-4% of the general population,^(2) In Japan, it is estimated
that there are 2 million people with chronic sinusitis, of which about 200,000 are
subject to surgery due to nasal polyps.^(3) CRSwNP is caused by chronic inflammation
of the nasal lining.^(2) Elevated levels of IL-5 are associated with CRSwNP as a
result of T2 inflammation, which can cause soft tissue growth, known as nasal polyps
that develop in the sinuses and nasal cavity.^(2) People with CRSwNP experience 
symptoms such as nasal obstruction, loss of smell, facial pressure, sleep disturbance
and nasal discharge.^(2) Surgery may be indicated for severe cases. However, polyps
have a strong tendency to reoccur, often leading to repeat surgery.^(2)

If approved, mepolizumab would be the first anti-IL-5 biologic for adult patients
with inadequately controlled CRSwNP in Japan. 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 current treatment.

**About the MERIT trial**

The primary endpoints were change from baseline in total endoscopic nasal polyp 
score at week 52 and change from baseline in mean nasal obstruction visual analogue
scale (VAS) score during the 4 weeks prior to week 52.^(1) The co-primary endpoints
were met, and the efficacy and safety of mepolizumab in the Japanese population 
were consistent with results from global trials.^(1,2)  

**About GSK’s _Nucala_ (mepolizumab)**

First approved in 2015 for severe eosinophilic asthma (SEA) in the US, mepolizumab
is a unique monoclonal antibody that targets and binds to interleukin-5 (IL-5), 
the major cytokine responsible for the maturation and activation of eosinophils.
^(4) The administration of mepolizumab has shown to reduce the number of blood eosinophils
and maintain them within normal levels (normal level of blood eosinophils being 
less than 500 eosinophils/microliter).^(4) Mepolizumab has been developed for the
treatment of a range of IL-5 mediated diseases identified by elevated blood eosinophil
counts.^(4) Mepolizumab has been studied in over 4,000 patients in 41 clinical trials
across several indications.

**References**

1.             National Library of Medicines (U.S.) (2021, February – 2023, April)
Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal

                Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS) (MERIT)
NCT04607005 https://classic.clinicaltrials.gov/ct2/show/NCT04607005

2.             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

3.             Homepage of the Japan Intractable Diseases Information Center https://
www.nanbyou.or.jp/ Eosinophilic sinusitis (Designated intractable disease 306)

4.             Nucala (mepolizumab) SmPC available at https://www.medicines.org.
uk/emc/product/10563/smpc last accessed August 2023.

_GSK is a global biopharma company with a purpose to unite science, technology, 
and talent to get ahead of disease together._

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