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
β2-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.
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 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)
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/
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