TIDMGSK
RNS Number : 3252X
GlaxoSmithKline PLC
23 November 2017
Issued: Thursday 23 November 2017, London UK - LSE
Announcement
GSK submits landmark IMPACT data to US regulatory authority to
support expanded label for Trelegy Ellipta
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced the filing of a supplemental New Drug
Application (sNDA) with the US Food and Drug Administration (FDA)
for the use of Trelegy Ellipta (fluticasone
furoate/umeclidinium/vilanterol, 'FF/UMEC/VI') for an expanded
indication for the maintenance treatment of airflow obstruction and
reduction of exacerbations in patients with chronic obstructive
pulmonary disease (COPD). Approval of this sNDA means FF/UMEC/VI
could be used by physicians to treat a wider population of patients
with COPD who are at risk of an exacerbation and require triple
therapy.
FF/UMEC/VI is the first treatment to provide a combination of
three molecules in a single inhaler that only needs to be taken
once a day. It contains an inhaled corticosteroid, a long-acting
muscarinic antagonist and a long-acting beta2-adrenergic agonist,
delivered once daily in GSK's Ellipta dry powder inhaler, which is
used across the entire new portfolio of inhaled COPD medicines.
Patrick Vallance, President, R&D, GSK said, "Data from GSK's
landmark IMPACT study provide important information on the efficacy
and safety of these molecules combined in a single inhaler and the
benefit they can bring to appropriate patients when delivered as a
triple combination therapy. We have moved swiftly to file these
data with the FDA."
In the IMPACT study FF/UMEC/VI showed superiority to the dual
combination therapies (FF/VI and UMEC/VI) on multiple endpoints,
including exacerbation rates, lung function and health related
quality of life. This builds on substantial evidence from across
multiple clinical programmes that has 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 for use in the US on 18 September 2017
for the long-term, once-daily, maintenance treatment of COPD
patients who are receiving Breo (FF/VI) and require additional
bronchodilation or who are receiving Breo and Incruse (UMEC). If
approved, the sNDA would broaden this indication.
Michael Aguiar, CEO of Innoviva added: "Trelegy Ellipta adds to
the portfolio of Ellipta inhaled therapies, which has been
developed because patients have different treatment needs. We
believe the IMPACT data will provide clarity to physicians on how
to treat patients based on their symptoms and risk profile and that
Trelegy Ellipta will play an important role in treating patients
who remain symptomatic and at risk of an exacerbation despite
current therapy."
About IMPACT
The regulatory submission is based on the positive results of
the landmark 10,355-patient InforMing the PAthway of COPD Treatment
(IMPACT) study. IMPACT evaluated the annual rate of on-treatment
moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg)
compared with FF/VI and UMEC/VI, two once-daily dual COPD therapies
from GSK's existing portfolio. Headline results were announced
earlier this year and full data will be presented in peer-reviewed
publications and future scientific meetings.
Further regulatory submissions with these data in other
countries including the EU are expected in 2018.
About COPD
COPD is a progressive lung disease that is thought to affect
around 384 million people worldwide.(1)
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.(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 (FF/UMEC/VI)
FF/UMEC/VI is the first single inhaler triple therapy approved
in the US 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 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. It is not
indicated for relief of acute bronchospasm or the treatment of
asthma.
FF/UMEC/VI 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, with which fewer patients make critical
errors compared to other commonly used inhalers.
Full US Prescribing Information, including BOXED WARNING and
Medication Guide are available at:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Trelegy/pdf/TRELEGY-PI-MG-IFU.PDF
On 16 November 2017, FF/UMEC/VI was granted marketing
authorisation 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.
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.
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 four 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) for Trelegy Ellipta
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.
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 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.
Trade marks 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
Trelegy Ellipta for COPD. For more information, please visit
Innoviva's website at www.inva.com.
GSK enquiries:
Global Media Simon Steel +44 (0) 20 (London)
enquiries: 8047 5502
David Daley +44 (0) 20 (London)
8047 5502
US Media enquiries: Karen Hagens +1 919 483 (North Carolina)
2863
Juan Carlos +1 919 483 (North Carolina)
Molina 0471
Sarah Spencer +1 215 751 (Philadelphia)
3335
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) 238-9605 (Brisbane,
investor.relations@inva.com Calif.)
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 September 30, 2017,
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).
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
References (accessed October 2017)
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/
This information is provided by RNS
The company news service from the London Stock Exchange
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