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 21 September
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: 21 September
2018, London UK - LSE Announcement
Trelegy Ellipta receives positive CHMP opinion
supportingexpanded COPD indication in Europe
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) announced that the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) has issued a
positive opinion today supporting the use of Trelegy Ellipta
(fluticasone furoate/umeclidinium/ vilanterol 'FF/UMEC/VI') in a
broader group of patients with moderate to severe chronic
obstructive pulmonary disease (COPD) and that labelling, if
approved, will be updated to further reflect its effect on
exacerbations of COPD.
The expanded indication for the once-daily single inhaler
triple therapy would enable use by patients not
adequately treated by a long-acting muscarinic receptor antagonist
(LAMA) and long-acting b2-agonist (LABA). It would also reference
the effect on exacerbations based on data from the InforMing the
PAthway of COPD Treatment (IMPACT) study.
Dr. Hal Barron, Chief Scientific Officer and President,
R&D, GSK, said, "Many patients with COPD continue to
experience exacerbations despite taking dual bronchodilator
therapies. The landmark IMPACT study provided compelling evidence
on the role Trelegy Ellipta can play in reducing these debilitating
events. If approved, the indication will recognise this and be
expanded to enable more appropriate patients to access the
first once-daily single inhaler triple therapy."
The CHMP's recommendation is based on a type II
variation supported by data from the IMPACT study which showed
Trelegy Ellipta was superior to the inhaled corticosteroid
(ICS)/LABA Relvar/Breo Ellipta (FF/VI) and LAMA/LABA Anoro Ellipta
(UMEC/VI) in patients with moderate to severe COPD on multiple
clinically important endpoints, including reducing exacerbations
and improving lung function and health related quality of
life.
Dr Ted Witek, Senior Vice President and Chief Scientific Officer at
Innoviva, added: "We welcome the CHMP's recognition of the evidence
supporting use of once-daily single inhaler triple therapy in a
broader group of appropriate patients with COPD and look forward to
a decision from the European Commission in due
course."
Trelegy Ellipta was originally approved in the European Union (EU)
in November 2017 as a maintenance treatment in adult
patients with moderate to severe COPD who are not adequately
treated by a combination of an ICS and a LABA (for effects on
symptom control see section 5.1). The proposed new indication is as
a maintenance treatment in adult patients with moderate to severe
COPD who are not adequately treated by a combination of an ICS and
a LABA or a combination of a LABA and a LAMA (for effects on
symptom control and prevention of exacerbations see section
5.1).
A CHMP positive opinion is one of the final steps before a final
decision on the regulatory update is granted by the European
Commission.
About IMPACT
The landmark 10,355-patient InforMing the PAthway of COPD Treatment
(IMPACT)
study is the first study to directly compare three commonly-used
COPD combination treatment classes delivered using the same dose
and inhaler. It is the second of two Phase III studies designed to
investigate the efficacy and safety of FF/UMEC/VI in a single
inhaler compared to other commonly-used COPD combination
treatments.1
IMPACT evaluated as its primary endpoint the annual rate of
on-treatment moderate/severe exacerbations for FF/UMEC/VI
(100/62.5/25mcg) compared with its components, FF/VI (100/25mcg)
and UMEC/VI (62.5/25mcg), two once-daily dual COPD therapies from
GSK's existing portfolio. Results from IMPACT were recently
published in the New England Journal of
Medicine.2
About Trelegy Ellipta (FF/UMEC/VI)
FF/UMEC/VI is the first COPD treatment to provide a combination of
three molecules in a single inhaler that is taken in a single
inhalation, once a day. It contains fluticasone furoate, an inhaled
corticosteroid, umeclidinium, a long-acting muscarinic antagonist;
and vilanterol, a long-acting beta2-adrenergic agonist, delivered
in GSK's Ellipta dry powder inhaler, which is used across the
entire new portfolio of inhaled COPD medicines.
Data from across multiple clinical programmes have demonstrated the
benefit/risk of the molecules in FF/UMEC/VI alone and in
combination for the treatment of COPD and it has been approved for
use in appropriate patients with COPD in both the US and the
EU.
FF/UMEC/VI was originally approved for use in the European Union in
November 2017 as a maintenance treatment in adult patients
with moderate to severe COPD who are not adequately treated by a
combination of an inhaled corticosteroid and a long-acting
beta2-agonist. The European Summary of Product Characteristics
is available at:https://www.medicines.org.uk/emc/medicine/34357
FF/UMEC/VI is approved in the US for the long-term,
once-daily, maintenance treatment of airflow obstruction in
patients with COPD, including chronic bronchitis and/or emphysema.
It is also indicated to reduce exacerbations of COPD in patients
with a history of exacerbations. It is not indicated for relief of
acute bronchospasm or for the treatment of asthma. Full US
Prescribing Information, including Patient Information is available
at:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Trelegy/pdf/TRELEGY-PI-MG-IFU.PDF
FF/UMEC/VI has been approved in a number of other countries with
further regulatory applications ongoing.
About COPD
COPD is a progressive lung disease that is thought to affect around
384 million people worldwide.3
For people living with COPD, the inability to breathe normally can
consume their daily lives and make simple activities, like walking
upstairs, an everyday struggle. Patients with COPD suffer from
symptoms of breathlessness and many have a significant risk of
exacerbations. Managing these aspects of the disease drives
physician treatment choice.
Long-term exposure to inhaled 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.4
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.
GSK's commitment to respiratory disease
GSK has led the way in developing innovative medicines to advance
the management of asthma and COPD for nearly 50 years. Over the
last five years we have launched six innovative medicines
responding to continued unmet patient need, despite existing
therapies. This is an industry-leading portfolio in breadth, depth
and innovation, developed to reach the right patients, with the
right treatment.
We remain at the cutting-edge of scientific research into
respiratory medicine, working in collaboration with patients and
the scientific community to offer innovative medicines aimed at
helping to treat patients' symptoms and reduce the risk of their
disease worsening. While respiratory diseases are clinically
distinct, there are important pathophysiological features that span
them, and our ambition is to have the most comprehensive portfolio
of medicines to address a diverse range of respiratory diseases. To
achieve this, we are focusing on targeting the underlying
disease-driving biological processes to develop medicines with
applicability across multiple respiratory diseases. This approach
requires extensive bioinformatics, data analytic capabilities,
careful patient selection and stratification by phenotype in our
clinical trials.
Important Safety Information for FF/UMEC/VI in the EU
The following Important Safety Information is based on a summary of
the Summary of Product Characteristics for Trelegy Ellipta
(FF/UMEC/VI). Please consult the full Summary of Product
Characteristics for all the safety information.
FF/UMEC/VI is contraindicated in patients with hypersensitivity to
either fluticasone furoate (FF), umeclidinium (UMEC), vilanterol
(VI) or any of the excipients.
FF/UMEC/VI should not be used in patients with asthma since it has
not been studied in this patient population. FF/UMEC/VI is not
indicated for the treatment of acute episodes of
bronchospasm.
In the event of deterioration of COPD during treatment with
FF/UMEC/VI, a re-evaluation of the patient and of the COPD
treatment regimen should be undertaken.
Administration of FF/UMEC/VI may produce paradoxical bronchospasm
that may be life-threatening.
Cardiovascular effects, such as cardiac arrhythmias e.g. atrial
fibrillation and tachycardia, may be seen after the administration
of muscarinic receptor antagonists and sympathomimetics, including
FF/UMEC/VI. Therefore, FF/UMEC/VI should be used with caution in
patients with unstable or life-threatening cardiovascular
disease.
Systemic steroid effects may occur with any inhaled corticosteroid
(ICS), particularly at high doses prescribed for long
periods. These effects are much less likely to occur than
with oral corticosteroids. Patients with moderate to severe hepatic
impairment receiving FF/UMEC/VI should be monitored for systemic
corticosteroid-related adverse reactions.
If a patient presents with symptoms such as blurred vision or other
visual disturbances, the patient should be considered for referral
to an ophthalmologist for evaluation of possible causes which may
include cataract, glaucoma or rare diseases such as central serous
chorioretinopathy (CSCR) which have been reported after use of
systemic and topical corticosteroids.
FF/UMEC/VI should be used with caution in patients with convulsive
disorders or thyrotoxicosis, in patients who are unusually
responsive to beta2-adrenergic
agonists and in patients with pulmonary tuberculosis or in patients
with chronic or untreated infection.
Consistent with its antimuscarinic activity, FF/UMEC/VI should be
used with caution in patients with urinary retention or with
narrow-angle glaucoma.
An increase in the incidence of pneumonia, including pneumonia
requiring hospitalisation, has been observed in patients with COPD
receiving ICS. There is some evidence of an increased risk of
pneumonia with increasing steroid dose but this has not been
demonstrated conclusively across all studies. There is no
conclusive clinical evidence for intra-class differences in the
magnitude of the pneumonia risk among ICS products.
Beta2-adrenergic
agonists may produce significant hypokalaemia in some patients,
which has the potential to produce adverse cardiovascular effects.
The decrease in serum potassium is usually transient, not requiring
supplementation. No clinically relevant effects of hypokalaemia
were observed in clinical studies with FF/UMEC/VI at the
recommended therapeutic dose. Caution should be exercised when
FF/UMEC/VI is used with other medicinal products that also have the
potential to cause hypokalaemia.
Beta2-adrenergic
agonists may produce transient hyperglycemia in some patients. No
clinically relevant effects on plasma glucose were observed in
clinical studies with FF/UMEC/VI at the recommended therapeutic
dose. Upon initiation of treatment with FF/UMEC/VI, plasma glucose
should be monitored more closely in diabetic
patients.
There have been reports of increases in blood glucose levels in
diabetic patients treated with fluticasone
furoate/umeclidinium/vilanterol and this should be considered when
prescribing to patients with a history of diabetes
mellitus.
This medicinal product contains lactose. Patients with rare
hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take
FF/UMEC/VI.
The most frequently reported adverse reactions with FF/UMEC/VI were
nasopharyngitis (7%), headache (5%) and upper respiratory tract
infection (2%). Other common adverse reactions (reported with a
frequency of ≥1/100 to <1/10) include: pneumonia,
pharyngitis, rhinitis, influenza, cough, arthralgia and back
pain.
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.
Innoviva - Innoviva is focused on bringing
compelling medicines to patients in areas of unmet need by
leveraging its significant expertise in the development,
commercialization and financial management of bio-pharmaceuticals.
Innoviva's portfolio is anchored by the respiratory assets
partnered with Glaxo Group Limited (GSK), including
RELVAR®/BREO® ELLIPTA®,
ANORO® ELLIPTA® and
TRELEGY® ELLIPTA®,
which were jointly developed by Innoviva and GSK. Under the
agreement with GSK, Innoviva is eligible to receive associated
royalty revenues from RELVAR®/BREO® ELLIPTA® and
ANORO® ELLIPTA®.
In addition, Innoviva retains a 15 percent economic interest in
future payments made by GSK for TRELEGY® ELLIPTA® and
earlier-stage programs partnered with Theravance Biopharma, Inc.
For more information, please visit Innoviva's website
at www.inva.com.
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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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US Media enquiries:
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Karen Hagens
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+1 919 483 2863
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(North Carolina)
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Sarah Spencer
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+1 215 751 3335
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(Philadelphia)
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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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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Danielle Smith
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+44 (0) 20 8047 7562
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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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Innoviva, Inc. enquiries:
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Investor and Media:
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Dan Zacchei / Alex Kovtun
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+1 (212) 446 9500
dzacchei@sloanepr.com /
akovtun@sloaneprr.com
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(California)
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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
2017.
Innoviva forward-looking statements
This press release contains
certain "forward-looking" statements as that term is defined in the
Private Securities Litigation Reform Act of 1995 regarding, among
other things, statements relating to goals, plans, objectives and
future events, including the development, regulatory and commercial
plans for closed triple combination therapy and the potential
benefits and mechanisms of action of closed triple combination
therapy. Innoviva intends such forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 21E of the Securities Exchange Act
of 1934 and the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements involve substantial risks,
uncertainties and assumptions. These statements are based on the
current estimates and assumptions of the management of Innoviva as
of the date of this press release and are subject to risks,
uncertainties, changes in circumstances, assumptions and other
factors that may cause the actual results of Innoviva to be
materially different from those reflected in the forward-looking
statements. Important factors that could cause actual results to
differ materially from those indicated by such forward-looking
statements are described under the headings "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and
Results of Operations" contained in Innoviva's Annual Report on
Form 10-K for the year ended December 31, 2017, which is on file
with the Securities and Exchange Commission (SEC) and available on
the SEC's website at www.sec.gov. Additional factors may be
described in those sections of Innoviva's Quarterly Report on Form
10-Q for the quarter ended March 31, 2018, to be filed with the SEC
in the second quarter of 2018. In addition to the risks described
above and in Innoviva's other filings with the SEC, other unknown
or unpredictable factors also could affect Innoviva's results. No
forward-looking statements can be guaranteed and actual results may
differ materially from such statements. Given these uncertainties,
you should not place undue reliance on these forward-looking
statements. The information in this press release is provided only
as of the date hereof, and Innoviva assumes no obligation to update
its forward-looking statements on account of new information,
future events or otherwise, except as required by law.
(INVA-G)
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References (accessed September 2018)
1.
Lipson DA et al. FULFIL Trial: Once-Daily Triple Therapy for
Patients with Chronic Obstructive Pulmonary Disease. Am J Resp Crit
Care Med. 2017.
2.
Lipson DA et al. Once-Daily Single Inhaler Triple Versus Dual
Therapy in Patients with COPD. New England Journal of Medicine.
2018.
3. Global
Strategy for the Diagnosis, Management and Prevention of COPD,
Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017.
Available from: http://goldcopd.org.
4. Diagnosis of COPD. World Health
Organization. Available at:
http://www.who.int/respiratory/copd/diagnosis/en/
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.
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GlaxoSmithKline plc
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(Registrant)
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Date: September
21, 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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