TIDMGSK
RNS Number : 2534R
GlaxoSmithKline PLC
20 September 2017
Issued: 20 September 2017, London UK - LSE Announcement
GSK and Innoviva report positive headline results from IMPACT
study showing single inhaler triple therapy Trelegy Ellipta reduced
COPD exacerbations
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 FEV(1) 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
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 the most
frequent serious adverse events were worsening of COPD: 11%, 11%
and 13% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively; and
pneumonia: 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 that the
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 beta(2) -agonist.
On 18 September 2017, GSK and Innoviva, Inc. announced that the
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 IMPACT
The 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 FF/VI (100mcg/25mcg) and UMEC/VI
(62.5mcg/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 FF/VI and, FF/UMEC/VI versus UMEC/VI. Other
endpoints included lung function and patient reported outcomes,
including health related quality of life measures.
About COPD
COPD 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
GSK's work.
About Trelegy Ellipta
Trelegy 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 beta(2) -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 Ellipta
The 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 beta(2) -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 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 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.
Trademarks are owned by or licensed to the GSK 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(R) /BREO(R) ELLIPTA(R) and ANORO(R)
ELLIPTA(R) , which were jointly developed by Innoviva and GSK.
Under the agreement with GSK, Innoviva is eligible to receive
associated royalty revenues from RELVAR(R) /BREO(R) ELLIPTA(R) ,
ANORO(R) ELLIPTA(R) . 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 enquiries:
UK Media enquiries: Simon Steel +44 (0) 20 (London)
8047 5502
David Daley +44 (0) 20 (London)
8047 5502
US Media enquiries: Sarah Spencer +1 215 751 (Philadelphia)
3335
Karen Hagens +1 919 483 (North Carolina)
2853
Juan Carlos +1 919 483 (North Carolina)
Molina 0471
Analyst/Investor Sarah Elton-Farr +44 (0) 20 (London)
enquiries: 8047 5194
Tom Curry + 1 215 751 (Philadelphia)
5419
Gary Davies +44 (0) 20 (London)
8047 5503
James Dodwell +44 (0) 20 (London)
8047 2406
Jeff McLaughlin +1 215 751 (Philadelphia)
7002
Innoviva, Inc. enquiries:
Investor relations: Eric d'Esparbes +1 (650) (Brisbane,
238 9605 Calif)
GSK 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 2016.
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, 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 Road
Brentford, Middlesex
TW8 9GS
References
1. 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
2. Diagnosis of COPD. World Health Organisation. Available at: http://www.who.int/respiratory/copd/diagnosis/en/]
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