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 August, 2019
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 . . . . . . . .
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as permitted by Regulation S-T Rule 101(b)(1): ____
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Issued: Thursday 1 August, London UK - LSE
announcement
Nucala receives EU approval for self-administration by patients
with severe eosinophilic asthma
96% of patients in studies preferred self-administration at home
over being treated in clinic
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the
European Commission has granted marketing authorisation for two new
methods of administering Nucala (mepolizumab): a pre-filled pen and
a pre-filled safety syringe. This is the only monthly* anti-IL5
biologic approved in Europe that people with severe eosinophilic
asthma can take at home, after a healthcare professional decides it
is appropriate.
Dr Hal Barron, Chief Scientific Officer and President, R&D,
GSK, said: "Making Nucala available for patients to take in the
convenience of their own home is an important advance that builds
on its proven efficacy, reflecting our ongoing efforts to meet the
needs of patients with complex diseases."
Severe eosinophilic asthma can have a life-changing impact, with
patients experiencing asthma symptoms that remain uncontrolled
despite high-dose standard treatments. This can leave them
struggling to breathe and at increased risk of a potentially fatal
asthma attack.1,2
The first European launches of the new administration options are
expected to take place in August 2019. The original
lyophilised version remains available, giving healthcare
professionals a choice of three different administration options to
best fit in with their patients' lives.
The marketing authorisation is supported by positive experience
data from two real-world open-label, single-arm, phase 3a studies
(NCT03099096 & NCT03021304). By the conclusion of the studies,
patients and caregivers were able to successfully self-administer
Nucala with the pre-filled pen and pre-filled safety syringe after
appropriate training (98% and 100% respectively). 96% of patients
preferred the at-home administration options compared to in-clinic
administration.
A further open-label, parallel-group, single-dose study
(NCT03014674), confirmed that the pharmacokinetic and
pharmacodynamic profile of Nucala administered via the pre-filled
safety syringe or pre-filled pen was comparable to the originally
approved lyophilised formulation.
*once every four weeks.
About Nucala (mepolizumab)
First approved in 2015 for severe eosinophilic asthma, 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 without
completely depleting them.
Mepolizumab has been developed for the treatment of diseases that
are driven by inflammation caused by eosinophils. It has been
studied in over 3,000 patients in 21 clinical trials across a
number of eosinophilic indications and is the only biologic with
4.8 years of safety and efficacy data in severe eosinophilic asthma
(SEA). Mepolizumab is approved (under the brand name Nucala) in the
US, Europe and in over 20 other markets as an add-on maintenance
treatment for patients with SEA. It is also the only anti-IL-5
biologic approved for paediatric use from ages six to 17 in Europe
in SEA. In the US, Japan, Canada and a number of other markets, it
is also approved as add-on maintenance treatment for patients with
eosinophilic granulomatosis with polyangiitis
(EGPA). Mepolizumab is currently being investigated for severe
hypereosinophilic syndrome, nasal polyposis and COPD.
In Europe, Nucala is indicated as an add-on treatment for severe
refractory eosinophilic asthma in adults, adolescents and children
aged 6 years and older. Nucala 100mg solution for injection in
pre-filled pen and pre-filled safety syringe are only appropriate
for use by adults and adolescents aged 12 years and over and are
not indicated for administration to children aged 6 to 11 years
old. This population should be treated with the lyophilised powder
(40mg) for solution for injection.
About severe asthma and eosinophilic inflammation
Severe asthma is defined as asthma which requires treatment with
high dose inhaled corticosteroids (ICS) plus a second controller
(and/or systemic corticosteroids) to prevent it from becoming
'uncontrolled' or which remains 'uncontrolled' despite this
therapy. Severe asthma patients are also often categorised by
long-term use of oral corticosteroids (OCS). 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.
Interleukin-5 (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.
GSK's commitment to respiratory disease
For 50 years, GSK has led the way in developing medicines that
advance the management of asthma and COPD. From introducing the
world's first selective short-acting beta agonist in 1969, to
launching six treatments in five years to create today's
industry-leading respiratory portfolio, we continue to innovate so
we can reach the right patients, with the right treatment. Working
together with the healthcare community, we apply world-class
science to discover and understand the molecules that become the
medicines of tomorrow. We won't stand still until the simple act of
breathing is made easier for everyone.
Important safety information for Nucala (mepolizumab)
The following Important Safety Information is based on a summary of
the European Summary of Product Characteristics and Prescribing
Information for Nucala. Please consult the full Summary of
Product Characteristics and Prescribing Information for all the
safety information for Nucala.
Nucala is contraindicated in patients with hypersensitivity to
mepolizumab or to any of the excipients.
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.
In clinical studies in subjects with severe refractory eosinophilic
asthma, the most commonly reported adverse reactions during
treatment were headache, injection site reactions and back
pain. Headache was considered very common, occurring with a
frequency of ≥1/10. Common adverse drug reactions
(≥1/100 to <1/10) included: lower respiratory tract
infection, urinary tract infection, pharyngitis, hypersensitivity
reactions (systemic, allergic), nasal congestion, upper abdominal
pain, eczema, back pain, administration-related reaction (systemic,
non-allergic), local injection site reactions, and
pyrexia. Severe
allergic reactions (anaphylaxis) is a rare side effect (may affect
up to 1 in 1,000 people).
Injection site reactions (e.g., pain, erythema, swelling, itching,
and burning sensation) occurred at a rate of 8% in subjects treated
with Nucala compared with 3% in subjects treated with
placebo.
GSK - a science-led global
healthcare company with a special purpose: to help people do more,
feel better, live longer. For further information please
visit www.gsk.com
Trademarks are owned by or licensed to the GSK group of
companies.
GSK enquiries:
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UK
Media enquiries:
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Simon
Steel
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(London)
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Tim
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(London)
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US
Media enquiries:
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Evan
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(Philadelphia)
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Analyst/Investor
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Sarah
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James
Dodwell
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+44 (0)
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(London)
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Danielle
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+44 (0)
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Jeff
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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 under Item 3.D
Principal risks and uncertainties in the company's Annual Report on
Form 20-F for 2018.
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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1
Kerkhof M, et
al.Thorax.
2018;73:116-124.
2 Bush A &
Pavord ID. EMJ. 2018; 3(4):10-15.
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.
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GlaxoSmithKline plc
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(Registrant)
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Date: August
01, 2019
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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