GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced the submission of a regulatory application to
the Japanese Ministry of Health, Labour and Welfare (MHLW) for
once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI
100/62.5/25 mcg) under the proposed brand name of Trelegy Ellipta
for the treatment of adults with chronic obstructive pulmonary
disease (COPD). This is the first regulatory filing to be made in
Japan for a triple COPD therapy in a single inhaler.
Dave Allen, Head, Respiratory Therapy Area R&D, GSK, said:
“COPD is a debilitating lung disease affecting over five million
people in Japan. Many patients require combination treatment with
different types of medicines to reduce both symptoms and
exacerbations but there is currently no triple therapy available in
Japan delivered in a single inhaler. If approved, once-daily
FF/UMEC/VI delivered in the Ellipta would be an important
innovation in the management of COPD in Japan alongside our current
range of treatments.”1
The New Drug Application is primarily based on data from the
Phase III IMPACT study which included 378 patients from Japan. In
the overall study population, FF/UMEC/VI 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. Similar trends were observed in the
Japanese population for the primary endpoint as well as across
multiple secondary and supportive efficacy endpoints.
Dr Ted Witek, Senior Vice President and Chief Scientific Officer
at Innoviva added, “We are delighted to have filed a new drug
application for the first single inhaler triple therapy for the
treatment of COPD in Japan where the prevalence of COPD is of
public concern. We look forward to a decision from the MHLW, which,
if positive, would provide a new therapeutic option for appropriate
patients with COPD in Japan.”
The proposed indication is for the relief of various symptoms
with COPD (chronic bronchitis, pulmonary emphysema) (in the case
where concurrent use of inhaled corticosteroid, long-acting inhaled
beta2-agonist and long-acting inhaled anticholinergic drug is
required).
FF/UMEC/VI is currently licensed for use in the US, EU and a
number of other countries under the brand name Trelegy Ellipta. It
contains three molecules, an ICS, a LAMA and a LABA, delivered in
the Ellipta dry powder inhaler which is used across GSK’s new
portfolio of inhaled COPD medicines.
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.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 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 GSK’s 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 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 is approved in Europe 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 worldwide.
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 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.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 - 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 the management of
royalty revenues from the respiratory inhalers
RELVAR®/BREO® ELLIPTA®, ANORO®
ELLIPTA® and TRELEGY® ELLIPTA®, commercialized by Glaxo
Group Limited (GSK). 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 and
Innoviva’s Quarterly Report on Form 10-Q for the quarter ended
March 31, 2018, both of which are on file with the Securities and
Exchange Commission (SEC) and available on the SEC's website at
www.sec.gov. 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 April 2018)
- Fukuchi Y et al. Prevalence of COPD in
Japan: results from the NIPPON COPD epidemiology (NICE) study. Eur
Respir J. 2001.
- Lipson DA et al. FULFIL Trial:
Once-Daily Triple Therapy for Patients with Chronic Obstructive
Pulmonary Disease. Am J Resp Crit Care Med. 2017.
- Lipson DA et al. Once-Daily Single
Inhaler Triple Versus Dual Therapy in Patients with COPD. New
England Journal of Medicine. 2018.
- Global Strategy for the Diagnosis,
Management and Prevention of COPD, Global Initiative for Chronic
Obstructive Lung Disease (GOLD) 2017. Available
from: http://goldcopd.org.
- 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
8047 5502 (London)David Daley, +44 (0) 20 8047 5502 (London)orUS
Media enquiries:Karen Hagens, +1 919 483 2863 (North Carolina)Sarah
Spencer, +1 215 751 3335 (Philadelphia)orAnalyst/Investor
enquiries:Sarah Elton-Farr, +44 (0) 20 8047 5194 (London)James
Dodwell, +44 (0) 20 8047 2406 (London)Danielle Smith, +44 (0) 20
8047 7562 (London)Tom Curry, + 1 215 751 5419 (Philadelphia)Jeff
McLaughlin, +1 215 751 7002 (Philadelphia)orInnoviva, Inc.
enquiries:Investor Relations:Eric d’Esparbes, +1 (650) 238-9640
(Brisbane, Calif.)investor.relations@inva.com
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