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
28 June
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:
Wednesday 28 June 2017, London, UK
GSK announces US regulatory submission for mepolizumab in
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
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
therapy to corticosteroids for the treatment of adult patients with
Eosinophilic Granulomatosis with Polyangiitis (EGPA). EGPA is a
rare disease, characterised by widespread inflammation in the walls
of small blood vessels (vasculitis) which may lead to tissue and
organ damage. The disease may affect multiple organ systems and be
associated with symptoms of fatigue, muscle and joint pain and
weight loss.
Birgitte
Volck, head of rare diseases R&D at GSK, said: "The symptoms
associated with EGPA are diverse and patients often experience
delay in diagnosis. The burden of disease may be severe, preventing
patients from carrying out everyday activities and recurrent
relapses place them at risk of permanent tissue and organ damage.
If approved, mepolizumab will be the first treatment in the US
indicated for EGPA and has the potential to offer healthcare
professionals and patients a new treatment option to help improve
symptoms and disease control."
The
regulatory submission is based on results from a pivotal, 52-week
Phase III study which evaluated the efficacy and safety of
mepolizumab vs placebo as an add-on therapy to standard of care in
patients with relapsing and/or refractory EGPA.
Regulatory
filings in other countries are planned during the course of 2017
and 2018. Mepolizumab is not approved anywhere in the world for
EGPA.
About EGPA (previously known as Churg-Strauss
Syndrome)
Eosinophilic
Granulomatosis with Polyangiitis (EGPA) is a rare disease that
causes inflammation in the walls of small blood vessels (or
vasculitis). The global incidence is generally reported to be in
the range 1-4 per million, with an estimated prevalence of
approximately 14-45 per million. The mean age of diagnosis is 48
years and the disease can be life-threatening for some
patients.
In
EGPA, patients usually develop asthma initially, before the
vasculitis extends to inflammation in the walls of small blood
vessels that supply tissues in the lungs, sinuses, skin, nerves and
other organs. EGPA can result in damage to multiple organs in the
body and the symptoms common to most include extreme fatigue,
weight loss, muscle and joint pain, sinonasal symptoms and
breathlessness, all of which affect patients' ability to carry out
everyday activities without difficulty.
The
current approach to disease management is primarily based on
reduction of active inflammation and suppression of the immune
response through the use of corticosteroid therapy and concomitant
immunosuppressive therapy (e.g., methotrexate, azathioprine,
mycophenolate mofetil) and/or cytotoxic agents (e.g.,
cyclophosphamide). Although the use of these treatments can be
effective for establishing remission, patients remain vulnerable to
either the complications of the long-term use of these therapies,
or to the risk of relapse, particularly if the dose of
corticosteroid is reduced.
About mepolizumab
Mepolizumab
is a targeted anti-IL-5 monoclonal antibody. Mepolizumab binds
to the signalling protein IL-5, preventing it from binding to its
receptor on the surface of white blood cells called eosinophils.
Inhibiting IL-5 binding in this manner reduces blood, tissue and
sputum eosinophil levels.
Eosinophils
are believed to play a role in protecting the body against
infection. In some people, increased eosinophil levels can lead to
inflammation and play a role 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 the first-in-class
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. Trademarks are owned by or licensed to
the GSK group of companies.
Mepolizumab
is not approved anywhere in the world for EGPA.
Mepolizumab is also being investigated in chronic obstructive
pulmonary disease (in
phase
III
), eosinophilic
granulomatosis with polyangiitis (EPGA, also referred to as
Churg-Strauss syndrome, in
phase
III
), severe hypereosinophilic
syndrome (in
phase
III
), and severe atopic
dermatitis (phase II).
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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Fiona
McMillan
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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:
|
Anna
Padula
|
+1 215
751 4271
|
(Philadelphia)
|
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Sarah
Spencer
|
+1 215
751 3335
|
(Philadelphia)
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Analyst/Investor
enquiries:
|
Sarah
Elton-Farr
|
+44 (0)
20 8047 5194
|
(London)
|
|
Tom
Curry
|
+ 1 215
751 5419
|
(Philadelphia)
|
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Gary
Davies
|
+44 (0)
20 8047 5503
|
(London)
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James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(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 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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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: June
28, 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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