REG - GlaxoSmithKline PLC - Nucala approved in Europe for more indications

GSKAnnouncement

17/11/2021 07:05

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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.

 

***ENDS***

 

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

 

 

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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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