FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 07 November
2017
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Issued:
Tuesday 7 November 2017, London UK - LSE Announcement
GSK submits US regulatory application for mepolizumab in
eosinophilic chronic obstructive pulmonary disease
(COPD)
GlaxoSmithKline
plc (LSE/NYSE: GSK) today announced the submission of a
supplemental Biologics License Application (sBLA) to the United
States Food and Drug Administration (FDA), seeking approval of
mepolizumab, an interleukin-5 (IL-5) antagonist, as an add-on to
maintenance treatment for patients who have chronic obstructive
pulmonary disease (COPD) with an eosinophilic
phenotype.
The
submission includes phase III data from the previously
reported1,2 METREX and METREO
studies.
Mepolizumab
is not approved anywhere in the world for COPD. The submission to
the FDA is the first to a regulatory authority for mepolizumab
for COPD. Regulatory filings in other countries are planned during
the course of 2017 and 2018.
About COPD
COPD is
a disease of the lungs that includes chronic bronchitis, emphysema
or both and limits airflow to the lungs, interfering with normal
breathing. It is thought to affect 384 million people
worldwide.3
It is currently the fourth leading cause of death in
the world but is projected to be the third leading cause of death
by 2020.3
COPD is a heterogenous disease and eosinophilic inflammation exists
in a sub-set of patients.4,5
Long-term
exposure to lung irritants that damage the lungs and the airways
are usually the cause of COPD. Cigarette smoke, breathing in second
hand smoke, air pollution, chemical fumes or dust from the
environment or workplace can all contribute to COPD. Most people
who have COPD are at least 40 years old when symptoms
begin.6
For
people living with COPD the inability to breathe normally and
worsening of their symptoms can consume their daily life and make
simple activities, like walking upstairs, an everyday
struggle.
Every
person with COPD is different, with different needs, different
challenges and different goals. Understanding this, and providing
support to help meet these needs is the foundation of GSK's
work.
About mepolizumab
Mepolizumab is a first-in-class monoclonal antibody that targets
the signalling protein IL-5. Mepolizumab binds to IL-5, preventing
it from binding to its receptor on the surface of white blood cells
called eosinophils. Inhibiting IL-5 binding in this way reduces
blood eosinophils, which are believed to play a role in protecting
the body against infection, but in some people can cause
inflammation and are involved in the development of some
inflammatory diseases. Mepolizumab has been developed for the
treatment of diseases that are driven by inflammation caused by
eosinophils.
Mepolizumab is approved for use in the US under the brand name
Nucala as an add-on
maintenance treatment for patients with severe asthma aged 12 years
and older, and with an eosinophilic phenotype. Nucala has also been
approved for severe eosinophilic asthma in the EU, Japan and a
number of other countries worldwide, although the details of the
indications may vary.
Mepolizumab has been filed in the US for the treatment of adult
patients with eosinophilic granulomatosis with polyangiitis (EGPA).
It is also being investigated for severe hypereosinophilic
syndrome, nasal polyposis and atopic dermatitis.
Trademarks are owned by or licensed to the GSK group of
companies.
Important Safety Information for
Nucala in Severe Asthma with an Eosinophilic Phenotype (based on US
Prescribing Information)
Please consult the full Prescribing Information for all the
labelled safety information for Nucala.
CONTRAINDICATIONS
Nucala should not be administered to patients with a history of
hypersensitivity to mepolizumab or excipients in the
formulation.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (e.g. anaphylaxis, angioedema,
bronchospasm, hypotension, urticaria, rash) have occurred following
administration of Nucala. These reactions generally occur within
hours of administration but in some instances can have a delayed
onset (i.e. days). In the event of a hypersensitivity reaction,
Nucala should be discontinued.
Acute Asthma Symptoms or Deteriorating Disease
Nucala should not be used to treat acute asthma symptoms, acute
exacerbations, or acute bronchospasm.
Opportunistic Infections: Herpes Zoster
In controlled clinical trials, 2 serious adverse reactions of
herpes zoster occurred in subjects treated with Nucala compared to
none in placebo. Consider varicella vaccination if medically
appropriate prior to starting therapy with Nucala.
Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids (ICS)
abruptly upon initiation of therapy with Nucala.
Decreases in corticosteroid doses, if appropriate, should be
gradual and under the direct supervision of a
physician. Reduction
in corticosteroid dose may be associated with systemic withdrawal
symptoms and/or unmask conditions previously suppressed by systemic
corticosteroid therapy.
Parasitic (Helminth) Infection
It is
unknown if Nucala will
influence a patient's response against parasites. Treat patients
with pre-existing helminth infections before initiating therapy
with Nucala. If
patients become infected while receiving treatment with
Nucala
and do not respond to anti-helminth treatment, discontinue
treatment with Nucala until
infection resolves.
ADVERSE REACTIONS
The
most common adverse reactions (≥3% and more common than
placebo) reported in the first 24 weeks of two clinical trials with
Nucala (and
placebo) were: headache, 19% (18%); injection site reaction, 8%
(3%); back pain, 5% (4%); fatigue, 5% (4%); influenza, 3% (2%);
urinary tract infection 3% (2%); abdominal pain upper, 3% (2%);
pruritus, 3% (2%); eczema, 3% (<1%); and muscle spasm, 3%
(<1%).
Systemic
Reactions, including Hypersensitivity Reactions: In 3
clinical trials, 3% of subjects who received Nucala
experienced systemic (allergic and nonallergic) reactions compared
to 5% in the placebo group. Systemic allergic/hypersensitivity
reactions were reported by 1% of subjects who received Nucala
compared to 2% of subjects in the placebo group. Manifestations
included rash, pruritus, headache, and myalgia. Systemic
nonallergic reactions were reported by 2% of subjects who received
Nucala and 3%
of subjects in the placebo group. Manifestations included rash,
flushing, and myalgia. A majority of the systemic reactions were
experienced on the day of dosing. Reports of anaphylaxis have been
received postmarketing.
Injection
site reactions (e.g. pain, erythema, swelling, itching, burning
sensation) occurred at a rate of 8% in subjects treated with
Nucala
compared with 3% in subjects treated with placebo.
USE IN SPECIFIC POPULATIONS
The
data on pregnancy exposures from the clinical trials are
insufficient to inform on drug-associated risk. Monoclonal
antibodies, such as mepolizumab, are progressively transported
across the placenta in a linear fashion as pregnancy progresses;
therefore, potential effects on a foetus are likely to be greater
during the second and third trimesters of pregnancy.
GSK - one of the world's
leading research-based pharmaceutical and healthcare companies - is
committed to improving the quality of human life by enabling people
to do more, feel better and live longer. For further
information please visit www.gsk.com.
GSK enquiries:
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UK
Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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David
Daley
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Mary
Anne Rhyne
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+1 919
483 0492
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(North
Carolina)
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Karen
Hagens
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+1 919
483 2863
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(North
Carolina)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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Tom
Curry
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+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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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 2016.
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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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References
1. http://www.gsk.com/en-gb/media/press-releases/gsk-announces-phase-iii-results-published-in-nejm-of-mepolizumab-in-patients-with-eosinophilic-copd-at-risk-of-exacerbations/
2.
Pavord ID et al.
Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease.
New Engl J Med 2017;
377:1613-1629.
3. Global Initiative for Chronic
Obstructive Lung Disease Global Initiative for Chronic Obstructive
Lung Disease. 2017. Pocket guide to COPD diagnosis, management, and
prevention. Available at: http://goldcopd.org/wp-content/uploads/2016/12/wms-GOLD-2017-Pocket-Guide.pdf
4.
Brightling CE et al. Sputum
eosinophilia and the short term response to inhaled mometasone in
chronic obstructive pulmonary disease. Thorax 2005; 60:193-198
5. Saha
S et al. Eosinophilic
airway inflammation in COPD. Int J
Chron Obstruct Pulmon
Dis 2006;1:39-47
6. Diagnosis of COPD. World Health
Organisation. Available at: http://www.who.int/respiratory/copd/diagnosis/en/]
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: November
07, 2017
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By: 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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