Trelegy Ellipta met study primary endpoint demonstrating
reduction in exacerbations compared with the dual therapies Anoro
Ellipta and Relvar/Breo Ellipta in patients with COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced positive headline results from the landmark
phase III IMPACT study of Trelegy Ellipta, the first and only FDA
approved once-daily single inhaler triple therapy comprising an
inhaled corticosteroid (ICS), long-acting muscarinic antagonist
(LAMA) and long-acting beta agonist (LABA).
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol,
FF/UMEC/VI) is approved for the long-term, once-daily, maintenance
treatment of patients with chronic obstructive pulmonary disease
(COPD) who are receiving Breo (fluticasone furoate/vilanterol, FF/
VI) and require additional bronchodilation or who are receiving
Breo and Incruse (umeclidinium, UMEC).
The IMPACT study, which involved 10,355 patients, met its
primary endpoint demonstrating statistically significant reductions
in the annual rate of on-treatment moderate/severe exacerbations
for FF/UMEC/VI (100/62.5/25mcg) when compared with two, once-daily
dual COPD therapies from GSK’s existing portfolio. The study showed
a:
- 15% reduction for FF/UMEC/VI compared
with Relvar/Breo Ellipta (FF/VI,100/25mcg);0.91 vs 1.07 per year;
p<0.001
- 25% reduction for FF/UMEC/VI compared
with Anoro Ellipta (UMEC/VI, 62.5/25mcg);0.91 vs 1.21 per year;
p<0.001
In addition, statistically significant improvements were
observed across all pre-specified key secondary endpoints and
associated treatment comparisons:
- Change from baseline trough FEV1 at
week 52 for FF/UMEC/VI compared with FF/VI was 97mL; p<0.001 and
for FF/UMEC/VI compared with UMEC/VI was 54mL; p<0.001
- Change from baseline St George’s
Respiratory Questionnaire at week 52 for FF/UMEC/VI compared with
FF/VI was -1.8 units; p<0.001 and for FF/UMEC/VI compared with
UMEC/VI was -1.8 units; p<0.001
- Analysis of time to first on-treatment
moderate/severe COPD exacerbation demonstrated a 14.8% reduction in
risk for FF/UMEC/VI compared with FF/VI; p<0.001, and a 16.0%
reduction in risk for FF/UMEC/VI compared with UMEC/VI;
p<0.001
Based on review of the headline data, the safety profile of
once-daily FF/UMEC/VI was consistent with the known profile of the
individual medicines and their dual combinations. The most common
adverse events across the treatment groups were viral upper
respiratory tract infection, worsening of COPD, upper respiratory
tract infection, pneumonia and headache. The incidences of common
serious adverse events were worsening of COPD 11%, 11% and 13% for
FF/UMEC/VI, FF/VI and UMEC/VI, respectively; for pneumonia was 4%,
4% and 3% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively.
Patrick Vallance, President R&D, GSK, said: “We are
delighted with the positive results achieved in the IMPACT study.
This is the first study to report a comparison of a single inhaler
triple therapy with two dual therapies, providing much needed
clinical evidence about the ability of a single inhaler triple
therapy to reduce exacerbations. It is important to note that all
treatments were comprised of different combinations of the same
component molecules administered in the same Ellipta inhaler, in a
single dose, once a day to allow direct treatment comparisons. We
hope these results will inform global guidelines and look forward
to sharing the results with regulatory authorities. We will
continue to analyse the wealth of data generated to further the
understanding of the treatment of COPD.”
Mike Aguiar, CEO of Innoviva, Inc., commented: “The results of
the IMPACT study have been long awaited by the medical community.
We believe these data will significantly contribute to the body of
evidence on the use of single inhaler triple therapy, as well as
the ongoing role of ICS/LABA and LAMA/LABA treatments in
appropriate patients with COPD.”
Full results will be presented at upcoming scientific meetings
and in peer-reviewed publications.
On 14 September 2017 GSK and Innoviva, Inc. announced EU
Committee for Medicinal Products for Human Use (CHMP) issued a
positive opinion recommending marketing authorisation for Trelegy
Ellipta) as a maintenance treatment in adult patients with moderate
to severe chronic obstructive pulmonary disease (COPD) who are not
adequately treated by a combination of an inhaled corticosteroid
and a long-acting beta2-agonist.
On 18 September 2017 GSK and Innoviva, Inc. announced US Food
and Drug Administration (FDA) approved Trelegy Ellipta for the
long-term, once-daily, maintenance treatment of patients with
chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and/or emphysema, who are on a fixed-dose combination of
fluticasone furoate and vilanterol for airflow obstruction and
reducing exacerbations in whom additional treatment of airflow
obstruction is desired or for patients who are already receiving
umeclidinium and a fixed-dose combination of fluticasone furoate
and vilanterol. Trelegy Ellipta is not indicated for relief of
acute bronchospasm or the treatment of asthma.
Global regulatory filings with the IMPACT study are expected to
commence in the second quarter of 2018 for consideration of
expansion of the indicated patient population.
About IMPACTThe InforMing the PAthway of COPD Treatment
(IMPACT) study was a randomised, double-blind, 3-arm parallel
group, multicentre study evaluating FF/UMEC/VI
(100mcg/62.5mcg/25mcg) versus UMEC/VI (62.5mcg/25mcg) and FF/VI
(100mcg/25mcg), all given once daily via the ELLIPTA dry powder
inhaler. The total duration of the study was approximately 55 weeks
consisting of a 2-week run-in period, 52-week treatment period and
a 1-week safety follow-up period. Patients had moderate to very
severe symptomatic COPD with a history of exacerbation in the prior
12 months. In the study, 10,355 patients were treated in over 1,035
study centres globally.
The primary efficacy endpoint was the annual rate of
on-treatment moderate and severe exacerbations. This was compared
for FF/UMEC/VI versus UMEC/VI and, FF/UMEC/VI versus FF/VI. Other
endpoints included lung function and patient reported outcomes,
including health related quality of life measures.
About COPDCOPD is a disease of the lungs that includes
chronic bronchitis, emphysema or both and limits airflow to the
lungs, interfering with normal breathing. It is thought to affect
384 million people worldwide. 1
For people living with COPD the inability to breathe normally
and worsening of their symptoms can consume their daily life and
make simple activities, like walking upstairs, an everyday
struggle.
Long-term exposure to lung 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. 2
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 our
work.
About Trelegy ElliptaTrelegy Ellipta is the first
once-daily single inhaler triple therapy approved in the US for the
long-term, once-daily, maintenance treatment of patients with
chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and/or emphysema, who are on a fixed-dose combination of
fluticasone furoate and vilanterol for airflow obstruction and
reducing exacerbations in whom additional treatment of airflow
obstruction is desired or for patients who are already receiving
umeclidinium and a fixed-dose combination of fluticasone furoate
and vilanterol. Trelegy Ellipta is not indicated for relief of
acute bronchospasm or the treatment of asthma.
Trelegy contains fluticasone furoate, an inhaled corticosteroid,
umeclidinium, a long-acting muscarinic antagonist; and vilanterol,
a long-acting beta2-adrenergic agonist, in a single inhaler, the
Ellipta.
Full US Prescribing Information, including BOXED WARNING and
Medication Guide is available at: us.gsk.com.
Important Safety Information (ISI) for Trelegy ElliptaThe
following ISI is based on the Highlights section of the US
Prescribing Information for Trelegy Ellipta. Please consult the
full Prescribing Information for all the labelled safety
information for Trelegy Ellipta.
Long-acting beta2-adrenergic agonists (LABA),
such as vilanterol, increase the risk of asthma-related death. A
placebo-controlled trial with another LABA (salmeterol) showed an
increase in asthma-related deaths. This finding with salmeterol is
considered a class effect of all LABA. The safety and efficacy of
Trelegy Ellipta in patients with asthma have not been established.
Trelegy Ellipta is not indicated for the treatment of
asthma.
Trelegy Ellipta is contraindicated in patients with severe
hypersensitivity to milk proteins or any of the ingredients.
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 patents 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 headache, back pain, dysgeusia, diarrhea,
cough, oropharyngeal pain, and gastroenteritis.
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.
RELVAR®, BREO®, ANORO® and ELLIPTA® are trademarks of the
GlaxoSmithKline group of companies.
Innoviva – Innoviva is focused on bringing compelling new
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® and ANORO®
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®, ANORO® ELLIPTA®. In
addition, Innoviva retains a 15 percent economic interest in future
payments made by GSK for earlier-stage programs partnered with
Theravance Biopharma, Inc., including the closed triple combination
therapy for COPD. For more information, please visit Innoviva's
website at www.inva.com.
GSK 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.
Innoviva forward-looking statementsThis 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, 2016 and
Quarterly Report on Form 10-Q for the quarter ended June 30, 2017,
which are on file with the U.S. 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).
Registered in England & Wales:No. 3888792
Registered Office:980 Great West RoadBrentford,
MiddlesexTW8 9GS
References
- Global Initiative for Chronic
Obstructive Lung Disease Global Initiative for Chronic Obstructive
Lung Disease. 2017. Pocket guide to COPD diagnosis, management, and
prevention. Available at:
http://goldcopd.org/wp-content/uploads/2016/12/wms-GOLD-2017-Pocket-Guide.pdf
- Diagnosis of COPD. World Health
Organisation. Available at:
http://www.who.int/respiratory/copd/diagnosis/en/]
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170919006767/en/
GSK enquiries:UK Media enquiries:Simon Steel, +44 (0) 20
8047 5502 (London)David Daley, +44 (0) 20 8047 5502 (London)orUS
Media enquiries:Sarah Spencer, +1 215 751 3335 (Philadelphia)Karen
Hagens, +1 919 483 2853 (North Carolina)Juan Carlos Molina, +1 919
483 0471 (North Carolina)orAnalyst/Investor enquiries:Sarah
Elton-Farr, +44 (0) 20 8047 5194 (London)Tom Curry, + 1 215 751
5419 (Philadelphia)Gary Davies, +44 (0) 20 8047 5503 (London)James
Dodwell, +44 (0) 20 8047 2406 (London)Jeff McLaughlin, +1 215 751
7002 (Philadelphia)orInnoviva, Inc. enquiries:Investor
relations:Eric d’Esparbes, +1 (650) 238 9605 (Brisbane, Calif)
GSK (NYSE:GSK)
Historical Stock Chart
From Aug 2024 to Sep 2024
GSK (NYSE:GSK)
Historical Stock Chart
From Sep 2023 to Sep 2024