GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced that the US Food and Drug Administration
(FDA) has approved an expanded indication for Trelegy Ellipta
(fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), which
means Trelegy Ellipta can now be used by US physicians to treat a
broader population of chronic obstructive pulmonary disease (COPD)
patients with airflow limitation or who have experienced an acute
worsening of respiratory symptoms.
The new indication is 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.
Dr. Hal Barron, Chief Scientific Officer and President of
Research and Development, GSK, said, “Following the initial
approval of Trelegy Ellipta in September, we have
analysed the data from the IMPACT study and identified
additional benefits that this important medicine offers
patients with chronic obstructive pulmonary disease. We
are pleased that the robust data from the IMPACT study has
enabled the expanded indication announced today and the
FDA action has been taken so swiftly. We will continue to
analyse the data from the IMPACT trial and our
ongoing Trelegy Ellipta studies to demonstrate further
the value of this important medicine to patients.”
The approval is based on a supplemental New Drug Application
(sNDA) supported by data from the landmark InforMing the PAthway of
COPD Treatment (IMPACT) study which showed Trelegy Ellipta was
superior to the inhaled corticosteroid/long-acting beta2-adrenergic
agonist (ICS/LABA), Relvar/Breo Ellipta (FF/VI), and long-acting
muscarinic antagonist/long-acting beta2-adrenergic agonist
(LAMA/LABA), Anoro Ellipta (UMEC/VI), 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: “Up to half of patients with COPD on maintenance
therapy will have experienced at least one exacerbation in the past
12 months, so gaining an indication that reflects the role Trelegy
Ellipta can play in reducing this risk is important. We welcome
this regulatory update which will allow physicians to offer the
benefits of once-daily single inhaler triple therapy to appropriate
patients with COPD.”
Trelegy Ellipta was originally approved for use in the US in
September 2017 for the long-term, once-daily, maintenance treatment
of COPD patients who are receiving Breo and require additional
bronchodilation or who are receiving Breo and Incruse (UMEC). A
type II variation to support an expanded label in Europe was
submitted to the European Medicines Agency (EMA) in February 2018
and is currently under review.
The boxed warning has also been removed from the Trelegy Ellipta
prescribing information, in line with the recent updates to the
ICS/LABA class. Labelling changes to ICS/LABA combination medicines
were implemented following a review of safety data submitted to the
FDA by three companies including GSK and approved on December 20,
2017.
About IMPACT
The regulatory update is based on the positive results of the
landmark 10,355-patient InforMing the PAthway of COPD Treatment
(IMPACT) study. IMPACT 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 3 studies
designed to investigate the efficacy and safety of FF/UMEC/VI in a
single inhaler compared to other commonly-used COPD combination
treatments.2
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 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.3
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 of the molecules in FF/UMEC/VI both alone and in
combination, for the treatment of COPD.
FF/UMEC/VI was approved in the US in September 2017 for the
long-term, once-daily, maintenance treatment of patients with COPD,
including chronic bronchitis and/or emphysema, who are on a
fixed-dose combination of FF/VI for airflow obstruction and
reducing exacerbations in whom additional treatment of airflow
obstruction is desired or for patients who are already receiving
UMEC and a fixed-dose combination of FF/VI.
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 was approved for use in Europe 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
Regulatory applications for once-daily single inhaler triple
therapy FF/UMEC/VI have been submitted and are undergoing
assessment in a number of other countries.
About COPD
COPD is a progressive lung disease that is thought to affect
around 384 million people worldwide.4 For people living with COPD,
the inability to breathe normally can consume their daily lives and
make simple activities, like walking up stairs, 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.5
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 (ISI)
The following ISI is based on the Highlights section of the US
Prescribing Information for FF/UMEC/VI. Please consult the full
Prescribing Information for all the labelled safety
information.
Trelegy Ellipta is contraindicated in patients with severe
hypersensitivity to milk proteins or any of the ingredients.
LABA monotherapy increases the risk of serious asthma-related
events.
Trelegy Ellipta should not be initiated in patients experiencing
episodes of acutely deteriorating COPD. Do not use Trelegy Ellipta
to treat acute symptoms.
Trelegy Ellipta should not be used in combination with other
medicines containing LABA because of risk of overdose.
Candida albicans infection of the mouth and pharynx has occurred
in patients treated with fluticasone furoate, a component of
Trelegy Ellipta. Monitor patients periodically. Advise the patient
to rinse his/her mouth with water without swallowing after
inhalation to help reduce the risk.
There is an increased risk of pneumonia in patients with COPD
taking Trelegy Ellipta. Monitor patients for signs and symptoms of
pneumonia.
Patients who use corticosteroids are at risk for potential
worsening of infections (e.g. existing tuberculosis; fungal,
bacterial, viral, or parasitic infections; or ocular herpes
simplex). Use Trelegy Ellipta with caution in patients with these
infections. More serious or even fatal course of chickenpox or
measles can occur in susceptible patients.
There is a risk of impaired adrenal function when transferring
from systemic corticosteroids. Taper patients slowly from systemic
corticosteroids if transferring to Trelegy Ellipta.
Hypercorticism and adrenal suppression may occur with very high
dosages or at the regular dosage of Trelegy Ellipta in susceptible
individuals. If such changes occur, consider appropriate
therapy.
If paradoxical bronchospasm occurs, discontinue Trelegy Ellipta
and institute alternative therapy.
Use Trelegy Ellipta with caution in patients with cardiovascular
disorders because of beta-adrenergic stimulation.
Assess patients for decrease in bone mineral density initially
and periodically thereafter after prescribing Trelegy Ellipta.
Close monitoring for glaucoma and cataracts is warranted in
patients taking Trelegy Ellipta. Worsening of narrow-angle glaucoma
may occur. Use with caution in patients with narrow-angle glaucoma
and instruct patients to contact a healthcare provider immediately
if symptoms occur.
Worsening of urinary retention may occur in patients taking
Trelegy Ellipta. Use with caution in patients with prostatic
hyperplasia or bladder-neck obstruction and instruct patients to
contact a healthcare provider immediately if symptoms occur.
Use Trelegy Ellipta with caution in patients with convulsive
disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
Be alert to hypokalemia and hyperglycemia in patients taking
Trelegy Ellipta.
The most common adverse reactions reported for Trelegy Ellipta
(incidence ≥1%) are upper respiratory tract infection, pneumonia,
bronchitis, oral candidiasis, headache, back pain, arthralgia,
influenza, sinusitis, pharyngitis, rhinitis, dysgeusia,
constipation, urinary tract infection, diarrhea, gastroenteritis,
oropharyngeal pain, cough, and dysphonia.
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.
Trademarks 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)
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
References (accessed March 2018)
1. GSK data on file. RF/CPD/0003/18. Frequency of acute
exacerbations of COPD among patients treated with maintenance
therapy in three observational studies.
2. Lipson DA et al. FULFIL Trial: Once-Daily Triple Therapy for
Patients with Chronic Obstructive Pulmonary Disease. Am J Resp Crit
Care Med. 2017.
3. Lipson DA et al. Once-Daily Single Inhaler Triple Versus Dual
Therapy in Patients with COPD. New England Journal of Medicine.
2018.
4. Global Strategy for the Diagnosis, Management and Prevention
of COPD, Global Initiative for Chronic Obstructive Lung Disease
(GOLD) 2017. Available from: http://goldcopd.org.
5. Diagnosis of COPD. World Health Organization. Available at:
http://www.who.int/respiratory/copd/diagnosis/en/
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GSK enquiries:UK Media enquiries:Simon Steel, +44 (0) 20
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Relations:Eric d’Esparbes, +1 650-238-9640 (Brisbane,
Calif.)investor.relations@inva.com
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