UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of November 2021
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
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.
GSK enquiries:
|
|
|
|
Media
enquiries:
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
|
Madeleine
Breckon
|
+44 (0)
20 8047 5502
|
(London)
|
|
Kristen
Neese
|
+1 804
217 8147
|
(Philadelphia)
|
|
Kathleen
Quinn
|
+1 202
603 5003
|
(Washington
DC)
|
|
|
|
|
Analyst/Investor
enquiries:
|
Nick
Stone
|
+44 (0)
7717 618834
|
(London)
|
|
Sonya
Ghobrial
|
+44 (0)
7392 784784
|
(Consumer)
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(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 in the Company's
Annual Report on Form 20-F for 2020, GSK's Q3 Results and any
impacts of the COVID-19 pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
|
GlaxoSmithKline plc
|
|
(Registrant)
|
|
|
Date: November
17, 2021
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GlaxoSmithKline plc
|
GSK (PK) (USOTC:GLAXF)
Historical Stock Chart
From Aug 2024 to Sep 2024
GSK (PK) (USOTC:GLAXF)
Historical Stock Chart
From Sep 2023 to Sep 2024