TIDMGSK
RNS Number : 6091S
GlaxoSmithKline PLC
17 November 2021
Issued: 17 November 2021, London UK
European Commission approves Nucala (mepolizumab) in three
additional eosinophil-driven diseases
-- Approval for the first targeted treatment for eosinophilic
granulomatosis with polyangiitis and the first anti-IL-5 biologic
treatment for patients with hypereosinophilic syndrome or chronic
rhinosinusitis with nasal polyps in Europe
-- Mepolizumab is now the only treatment approved in Europe for
use in four eosinophil-driven diseases
GlaxoSmithKline (GSK) plc today announced that the European
Commission has approved Nucala (mepolizumab), a monoclonal antibody
that targets interleukin-5 (IL-5) , for use in three additional
eosinophil-driven diseases. This authorisation follows positive
opinions recommended by the Committee for Medicinal Products for
Human Use and authorises mepolizumab for use as an add on treatment
in hypereosinophilic syndrome (HES), eosinophilic granulomatosis
with polyangiitis (EGPA) and chronic rhinosinusitis with nasal
polyps (CRSwNP).
Eosinophil-driven diseases are inflammatory conditions
associated with elevated levels of eosinophils, a type of white
blood cell. CRSwNP is a condition in which patients develop soft
tissue growths called nasal polyps which can cause chronic symptoms
such as nasal obstruction, loss of smell and discharge. HES and
EGPA are both potentially life-threatening rare diseases arising
from inflammation in various tissues. The inflammation can cause a
range of symptoms which are frequently severe. Mepolizumab is the
first approved targeted treatment for EGPA and the first anti-IL-5
biologic treatment for patients with HES or CRSwNP in Europe. These
approvals make mepolizumab the only treatment approved in Europe
for use in four eosinophil-driven diseases as mepolizumab is
already approved for use in Europe as an add-on treatment for
patients aged six years and older with severe eosinophilic asthma
(SEA).
Dr. Hal Barron, Chief Scientific Officer and President R&D,
GSK, said: "With millions of patients across Europe affected by
eosinophil-driven diseases, we recognize the urgency in delivering
the first approved targeted treatment for use in four of these
conditions. Today's approvals reinforce the important role
treatments such as mepolizumab can play in helping to improve the
lives of patients with these debilitating diseases."
Individual country studies suggest that across Europe there are
up to 22 million people who have CRSwNP. Patients with CRSwNP,
particularly those with severe disease, may rely upon oral steroids
to manage the inflammation and can require repeated surgical
intervention due to recurrent growths to manage their condition.
Advances in biologic therapies are providing options for these
patients. Mepolizumab is now approved as an add-on therapy to
intranasal corticosteroids for the treatment of adult patients with
severe CRSwNP for whom therapy with systemic corticosteroids and/or
surgery do not provide adequate disease control.
Available data suggest that across Europe, roughly 7000 people
are affected by EGPA. EGPA is characterised by widespread
inflammation in the walls of small blood vessels (vasculitis). The
disease may affect multiple organ systems and be associated with
symptoms of fatigue, muscle and joint pain and weight loss. The
burden of disease may be high with patients experiencing recurrent
relapses which prevent them from carrying out everyday activities.
Currently, most patients with EGPA are treated with
anti-inflammatory corticosteroids or immunosuppressive medicines
(i.e. medicines that reduce the activity of the immune system)
which can lead to both short and long-term adverse effects.
Mepolizumab is now approved as an add-on treatment for patients
aged 6 years and older with relapsing-remitting or refractory
EGPA.
Up to 5,000 adults in Europe are affected by HES. When
eosinophils infiltrate certain tissues, they can cause inflammation
which can lead to organ damage which, over time, can impact
patients' day-to-day ability to function. Complications can range
from fever and malaise to respiratory and cardiac problems. The
symptoms of HES may become progressively worse and can be
life-threatening. HES can take many years to diagnose, and most
patients continue to suffer from debilitating flares of their
disease due to limited treatment options. Mepolizumab is now
approved as an add-on treatment for adult patients with
inadequately controlled HES without an identifiable
non-haematologic secondary cause.
EGPA and HES are both rare diseases and epidemiological data is
sparse, therefore the exact prevalence figures are unknown. It is
probable that numbers of patients with EGPA and HES are
underreported due to the rare nature of the conditions and delays
in diagnosis.
Tonya Winders, CEO & President, Allergy and Asthma Network
(AAN) and President of Global Allergy and Airways Patient Platform
(GAAPP) commented: "The lives of patients affected by an
eosinophil-driven disease are often impacted by what can be severe
or life-threatening symptoms. They may rely on both intermittent or
continuous oral steroids to manage their condition or be left
feeling they have no option but to endure ongoing symptoms and
possible flare-ups. The availability of mepolizumab, a targeted
biologic therapy, provides patients and their healthcare
professionals with a new option in their armamentarium to treat
hypereosinophilic syndrome, eosinophilic granulomatosis with
polyangiitis, and chronic rhinosinusitis with nasal polyps."
The three approvals are based on data from pivotal trials
investigating the role of targeted IL-5 inhibition with mepolizumab
in these eosinophil-driven diseases. The studies demonstrated:
-- In patients with HES, significantly fewer patients (15 of 54
[28%] vs 30 of 54 [56%]; P = .002) experienced a HES flare
(worsening of symptoms or eosinophil threshold requiring an
escalation in therapy) when treated with mepolizumab, compared to
placebo, when added to standard of care treatment over the 32-week
study period.
-- In adult patients with EGPA, mepolizumab increased both
accrued time in remission and proportion of patients achieving
remission compared to placebo when added to standard of care.
-- In adult patients with CRSwNP and at least one prior surgery,
over 70% of whom also had a diagnosis of asthma, mepolizumab
demonstrated significant improvements in both the size of nasal
polyps at the end of the 52-week study and in nasal obstruction
during weeks 49-52, compared to placebo when added to standard of
care, as well as reducing further surgeries up to week 52.
Epidemiological, clinical, and pathophysiological studies show
that CRSwNP and asthma are closely linked and often coexist.
Additionally, patients with EGPA usually also have asthma which can
frequently be severe. This overlap across eosinophil-driven
diseases underscores the importance of understanding the complex
role of eosinophils in disease.
Through ongoing research, GSK is committed to improving the
lives of those living with disease associated with uncontrolled
eosinophilic inflammation, continuously innovating to address the
unmet needs in this broad patient group.
***S***
About Nucala (mepolizumab)
First approved in 2015 for SEA, Nucala (mepolizumab) is the
first-in-class monoclonal antibody that targets 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. The mechanism of action for
mepolizumab has not been definitively established.
Nucala is available as a solution in a prefilled pen or syringe
or as a powder that comes in a vial and is made up into an
injection. The patient (adults and adolescents aged 12 years and
older) or caregiver can use Nucala prefilled pen or syringe
themselves if their healthcare professional determines that it is
appropriate, and the patient or caregiver are trained in injection
techniques, whereas the vial is only for use by a healthcare
professional.
Mepolizumab has been developed for the treatment of diseases
that are driven by inflammation caused by eosinophils. It has been
studied in over 4,000 patients in 41 clinical trials across several
eosinophilic indications and has been approved in the US, the EU
and in over 25 other markets, as an add-on maintenance treatment
for patients with SEA. Mepolizumab is approved in 17 markets,
including the EU US, for paediatric use in SEA from ages six to 17
years of age, with approval in an additional seven markets for use
in patients with SEA aged 12-17 years. The first approval for
mepolizumab in CRSwNP was granted by the FDA in July 2021.
Mepolizumab is approved for use in patients with EGPA in a total of
14 markets including the US, Japan and Canada. Mepolizumab was
first approved for use in HES in the US in September 2020 and
approvals have since then been granted in an additional 5 markets.
Mepolizumab is currently in clinical development for chronic
obstructive pulmonary disorder (COPD) and It is not currently
approved for use in COPD anywhere in the world.
About SEA
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. Severe asthma patients can also be categorised by
long-term use of oral corticosteroids. 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. IL-5 is the main promoter of eosinophil growth,
activation and survival and provides an essential signal for the
movement of eosinophils from the bone marrow into the lung. Studies
suggest that approximately 60% of patients with severe asthma have
eosinophilic airway inflammation.
About CRSwNP
CRSwNP is a chronic inflammatory disease of the nasal passage
linings or sinuses which leads to soft tissue growths known as
nasal polyps and is often characterised by elevated levels of
eosinophils. The resultant swellings typically grow in both
nostrils (bilateral) greatly impacting a patient due to various
symptoms including nasal obstruction, loss of smell, facial
pressure, and nasal discharge. Surgery may be indicated for severe
cases. However, polyps have a strong tendency to reoccur often
leading to repeat surgery.
About HES
HES is a rare and under-diagnosed disorder, making it difficult
to estimate its overall prevalence. Patients with HES have a
persistent and marked overproduction of eosinophils, a type of
white blood cell. When eosinophils infiltrate certain tissues, they
can cause inflammation and organ damage which, over time, can
impact patients' day-to-day ability to function. Complications can
range from fever and malaise to respiratory and cardiac problems.
If left untreated, the symptoms of HES become progressively worse
and the disease can be life-threatening.
About EGPA
EGPA is a chronic rare disease that is caused by inflammation in
the walls of small-to-medium sized blood vessels (vasculitis). In
EGPA, patients typically develop adult-onset asthma, and often
allergic rhinitis and sinusitis. EGPA can result in damage to
lungs, sinuses, skin, heart, gastrointestinal tract, nerves, and
other organs and can be life-threatening for some patients. The
most common symptoms include extreme fatigue, muscle and joint
pain, weight loss, sinonasal symptoms, and breathlessness.
Important safety information
The following Important Safety Information and Detailed
Recommendations for Use of this product will be described in the
updated summary of product characteristics, which will be published
in the revised European public assessment report, and will be
available in all official European Union languages after a decision
on this change to the marketing authorisation has been granted by
the European Commission.
Contraindications
Nucala is contraindicated in patients with hypersensitivity to
mepolizumab or to any of the excipients.
Warnings and precautions
Nucala has not been studied in patients with organ- or
life-threatening manifestations of EGPA, or in patients with
life-threatening manifestations of HES.
Nucala should not be used to treat acute asthma
exacerbations.
Asthma-related adverse symptoms or exacerbations may occur
during treatment. Patients should be instructed to seek medical
advice if their asthma remains uncontrolled or worsens after
initiation of treatment.
Abrupt discontinuation of corticosteroids after initiation of
Nucala therapy is not recommended. Reduction in corticosteroid
doses, if required, should be gradual and performed under the
supervision of a physician.
Acute and delayed systemic reactions, including hypersensitivity
reactions (e.g. anaphylaxis, urticaria, angioedema, rash,
bronchospasm, hypotension), have occurred following administration
of Nucala. These reactions generally occur within hours of
administration, but in some instances have a delayed onset (i.e.,
typically within several days). These reactions may occur for the
first time after a long duration of treatment.
Eosinophils may be involved in the immunological response to
some helminth infections. Patients with pre-existing helminth
infections should be treated for the helminth infection before
starting therapy with Nucala. If patients become infected whilst
receiving treatment with Nucala and do not respond to anti-helminth
treatment, temporary discontinuation of therapy should be
considered.
Undesirable effects
Very common (>=1/10): headache. Common (>=1/100 to
<1/10): lower respiratory tract infection, urinary tract
infection, pharyngitis, hypersensitivity reactions (systemic
allergic), nasal congestion, upper abdominal pain, eczema, back
pain, administration-related reactions (systemic non-allergic),
local injection site reactions, and pyrexia. Rare (up to 1/1,000):
severe allergic reactions (anaphylaxis).
About GSK
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/about-us .
GSK enquiries:
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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 in the Company's
Annual Report on Form 20-F for 2020, GSK's Q3 Results and any
impacts of the COVID-19 pandemic.
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