Blueprint
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 05 March
2018
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
5th March
2018, London UK - LSE Announcement
Nucala (mepolizumab) improved asthma control in patients
uncontrolled on Xolair (omalizumab)
Positive clinical study outcomes observed for severe eosinophilic
asthma patients uncontrolled on omalizumab when switched to
mepolizumab in an open-label single arm study
GlaxoSmithKline plc (LSE/NYSE: GSK) today presented positive results
from the OSMO study at the American Academy of Allergy, Asthma
& Immunology (AAAAI) and World Allergy Organization (WAO) Joint
Congress in Orlando. The results showed that severe asthma patients
who are uncontrolled despite receiving Xolair (omalizumab) and who
are eligible for treatment with Nucala (mepolizumab), experience
improved asthma control when switched on to mepolizumab.
OSMO is
an open-label, single-arm study which investigated whether patients
who had been receiving omalizumab, (a biologic targeting IgE in
patients with allergic sensitisation) for an average of 2.5 years
and continued to have uncontrolled severe asthma, gained better
asthma control following a switch to mepolizumab, (a biologic
targeting IL-5 for patients with severe eosinophilic asthma). In
the study 145 patients, who were documented to have experienced at
least two asthma exacerbations in the year prior to enrolment, were
switched directly to mepolizumab without a wash-out period and
followed for 32 weeks. In this study, mepolizumab data compared
with baseline values prior to first dose, unless otherwise
stated:
●
Met the primary endpoint of
asthma control with clinically significant improvements, as
evaluated by the Asthma Control Questionnaire (ACQ-5), with a mean
change from baseline of -1.45 at week 32
●
Met all secondary endpoints and
other key endpoints:
-
Rate of exacerbations requiring oral steroids reduced by 64% vs
prior 12 months (3.26 to 1.18)
-
Rate of exacerbations requiring an ED visit or hospitalization
reduced by 69% vs prior 12 months (0.63 to 0.19)
-
Improvement in lung function (pre-bronchodilator FEV1) of 159 mL vs
baseline
-
Improvement in Quality of life as evaluated by the SGRQ (-19 units,
compared with MCID -4.0) vs baseline
-
Reduction in blood eosinophils of approximately 80% by Week 4 (vs
baseline), which was sustained until Week 32
-
Safety profile was consistent with the known profile of the
treatment
Ken
Chapman, Professor of Medicine, University of Toronto and an
investigator in the OSMO study said: "Patients participating in
this study suffered burdensome day to day asthma symptoms and
frequently required access to urgent care when their asthma
symptoms significantly worsened. Like many similar patients, they
had both eosinophilic and allergic characteristics, making them
eligible to receive treatment with either omalizumab or
mepolizumab. OSMO showed us that when these patients remained
uncontrolled on omalizumab and were then switched to mepolizumab,
they experienced significant improvements - fewer symptoms,
better lung function, improved asthma-related quality of life and
fewer exacerbations. This study is a valuable addition to our
understanding of how to manage patients with biologic
therapies."
In a
further abstract/poster presented at AAAAI/WAO Joint Congress, a
pooled, post-hoc meta-analysis of data from the MENSA and MUSCA
studies, mepolizumab showed improvements in lung function of
patients with severe eosinophilic asthma, measured by morning peak
expiratory flow (AM PEF), compared with placebo. Early improvements
were seen in week one and sustained at the end of the observational
period: the mean change in AM PEF at week one was 10 L/min in the
mepolizumab group compared with 2L/min in the placebo group and at
the end of the observational period the mean change in AM PEF was
26 L/min in the mepolizumab group compared to 4 L/min in the
placebo group. This improvement was shown to be greater at higher
eosinophil counts.
Jonathan
Sweeting, SVP and Head, Global Respiratory Franchise, GSK said: "It
is important to have evidence to support decisions on prescribing
the right treatment to the right severe asthma patient. There is
existing data that supports the use of mepolizumab in patients with
severe eosinophilic asthma; with OSMO we wanted to understand how
to manage the more complex patients who are eligible to be treated
with omalizumab or mepolizumab. The results presented today provide
evidence that supports the use of mepolizumab in those eligible
patients who are not well controlled by omalizumab. In addition,
the meta-analysis we are presenting, which showed Nucala provides
an early improvement, sustained over time in lung function compared
with placebo, is further evidence supporting the effectiveness of
this treatment in patients with severe eosinophilic
asthma."
About the OSMO study
OSMO was an international, open-label, single arm trial. It
enrolled patients aged 12 and older with severe eosinophilic asthma
who were receiving omalizumab, but were not optimally controlled,
based on Asthma Control Questionnaire score of >1.5
at screening and baseline and who experienced >
2 exacerbations in the past 12
months. The Asthma Control Questionnaire (ACQ-5) is a validated,
self-administered tool, used by physicians to assess asthma control
and changes in asthma control. Patients also required a peripheral
eosinophil blood count of ≥150 cells/µL at study start
or ≥300 cells/µL in the past 12 months to be eligible
for mepolizumab.
About the meta-analysis
A
post-hoc meta-analysis of data from two randomised, double-blind,
placebo-controlled studies (MENSA and MUSCA) of 4-weekly
sub-cutaneous mepolizumab 100 mg (n=454) versus placebo (n=456) in
patients with severe eosinophilic asthma. All patients received
high dose ICS plus ≥1 controller medication, had ≥2
exacerbations in the previous year and blood eosinophils ≥150
cells/µL at screening or ≥300 cells/µL in the
previous year. The analysis assessed the effect of mepolizumab on
AM PEF based on study entry criteria and by eosinophil thresholds.
Data were analysed using a mixed model repeated measures
controlling for multiple covariates.
About Nucala (mepolizumab)
NUCALA is a market leading biologic treatment for patients with
severe asthma whose symptoms are driven by inflammation linked to
higher-than-normal eosinophils (a type of white blood cell) being
present in the blood. When
present in the body in normal levels, eosinophils can play a role
in protecting the body against infection but over-production can
cause inflammation in vital organs and tissues, sometimes
permanently damaging them.
When inflammation occurs in the lungs it can affect the
airways, making breathing difficult and increasing the frequency of
exacerbations or asthma attacks. Although the mechanism of action
has not been definitively established, Nucala is believed to work
by preventing the 'IL-5' cytokine from binding to its receptor on
the surface of eosinophil cells, which in turn reduces eosinophil
levels. The clinical trial programme to date has shown that Nucala
consistently reduced exacerbations, improved patient's quality of
life and maintains long term reduction of oral steroid
dose.
Mepolizumab has been studied in over 3,000 patients in 16 clinical
trials across a number of eosinophilic conditions, and is currently
being investigated for severe hypereosinophilic syndrome and nasal
polyposis.
Nucala 100mg is approved for the use as an add-on
treatment of patients with severe
eosinophilic asthma in over 40 countries including the EU, US, and
Japan and has been prescribed to over 18,000 patients in the
US. Mepolizumab 300mg is now approved in the US for the
treatment of adult patients with a rare disease called eosinophilic
granulomatosis with polyangiitis (EGPA). An sBLA
has also been filed for the treatment
in patients with chronic obstructive pulmonary disease
(COPD).
Nucala is a trade mark of the GSK group of companies.
In the US, Nucala (100mg fixed
dose subcutaneous injection of mepolizumab) is licensed as
an add-on maintenance treatment for
patients with severe asthma aged 12 years and older, and with an
eosinophilic phenotype. Nucala (3x 100mg subcutaneous injection of
mepolizumab) is licensed for the treatment of adult patients with
eosinophilic granulomatosis with polyangiitis (EGPA). Nucala is not
approved for the relief of acute bronchospasm or status
asthmaticus. Full US Prescribing
Information is available at US
Prescribing Information Nucala.
In the EU, Nucala (100mg fixed dose subcutaneous injection of
mepolizumab) is licensed as an add-on treatment for severe
refractory eosinophilic asthma in adult patients.
For the EU Summary of Product Characteristics for Nucala, please
visit:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003860/WC500198037.pdf
GSK's commitment to respiratory disease
GSK has
been developing new and first-in-class medicines, approaches and
insights, which have been leading scientific understanding of the
management of asthma and COPD for nearly 50 years. With the
broadest portfolio of treatments for people with asthma and COPD,
launched in the last four years, providing five new inhaled
treatments in a single inhaler device and a market-leading
biologic, our medicines are reaching the right patients, with the
right treatments, every day.
GSK is
relentless in striving to expand knowledge and understanding of
respiratory diseases to help address unmet need and transform the
way that medicines are developed. The company is focused on
applying our expertise to identify new scientific insights and
discover innovative new medicines in the disease areas of COPD,
where we are targeting fundamental drivers of disease; asthma and
severe asthma, to move from secondary prevention to primary disease
modification; and idiopathic pulmonary fibrosis and acute lung
injury where there is significant unmet need for new treatments; to
enable clinicians to treat the individual needs of patients, to
help patients to live every breath.
Important Safety Information for Nucala
The following information is based on the US Prescribing
Information for Nucala. 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 - 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
Trade marks 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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+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
Alspach
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+1 202
715 1048
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(Washington,
DC)
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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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)
208 047 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
statementsGSK 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: March
05, 2018
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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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