TIDMGSK
RNS Number : 6797W
GlaxoSmithKline PLC
16 November 2017
Issued: 16 November 2017, London UK - LSE Announcement
Trelegy Ellipta once-daily single inhaler triple therapy gains
marketing authorisation in Europe for the treatment of COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced that
the European Commission has granted marketing authorisation for
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol,
'FF/UMEC/VI') 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.
Trelegy Ellipta is the first once-daily single inhaler triple
therapy to be approved in Europe. It is a combination of an inhaled
corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA)
and a long-acting beta2-adrenergic agonist (LABA), delivered once
daily in GSK's Ellipta dry powder inhaler. The licensed strength as
delivered is FF/UMEC/VI 92/55/22 mcg.
Eric Dube, Senior Vice President & Head, GSK Global
Respiratory Franchise, said, "COPD is a serious lung disease that
affects millions of people. Its progressive nature means symptoms
can worsen over time with many patients also experiencing frequent
debilitating exacerbations. A combination of different types of
medicines can be required to achieve treatment goals. Trelegy
Ellipta is the first medicine to be approved in Europe that
delivers three effective molecules in a once-daily single
inhalation. We believe this is an important innovation in COPD
management and look forward to making it available for appropriate
patients with COPD."
Mike Aguiar, CEO of Innoviva, Inc. said, "Knowing that
appropriate COPD patients will require triple therapy, Trelegy
Ellipta affords the convenience of administration of three classes
of medicines in a single inhaler. Having all three major classes of
combination medication (ICS/LABA, LAMA/LABA, and now single inhaler
triple therapy) in the single Ellipta inhaler is an important
advance in inhaled therapeutics."
The first European launch is expected to take place before the
end of the year.
For the EU Summary of Product Characteristics please visit:
http://ec.europa.eu/health/documents/community-register/index_en.htm.
Prior to this being posted online, a copy may be requested from one
of the GSK Media or Investor Relations contacts listed in the "GSK
Enquiries" section at the end of this document.
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.
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 the Clinical Development Programme Supporting the European
Marketing Authorisation
The European Marketing Authorisation for FF/UMEC/VI is based on
efficacy and safety data from the FF/UMEC/VI development programme,
as well as data from studies with the components either alone, or
in combination. The results of the phase 3 FULFIL (Lung FUnction
and quality of LiFe assessment in COPD with closed trIpLe therapy)
study were published in 2017 (Lipson DA et al. Am J Resp Crit Care
Med 2017).
Other Regulatory Activity
On 18 September 2017, Trelegy Ellipta was approved for use 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.
Full US prescribing information, including BOXED WARNING and
Medication Guide are available at:
https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/trelegy/pi/home.html.
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.
Important Safety Information for FF/UMEC/VI in the EU
The following Important Safety Information is based on a summary
of the Summary of Product Characteristics for Trelegy Ellipta
(FF/UMEC/VI). Please consult the full Summary of Product
Characteristics for all the safety information.
FF/UMEC/VI is contraindicated in patients with hypersensitivity
to either fluticasone furoate (FF), umeclidinium (UMEC), vilanterol
(VI) or any of the excipients.
FF/UMEC/VI should not be used in patients with asthma since it
has not been studied in this patient population. FF/UMEC/VI is not
indicated for the treatment of acute episodes of bronchospasm.
In the event of deterioration of COPD during treatment with
FF/UMEC/VI, a re-evaluation of the patient and of the COPD
treatment regimen should be undertaken.
Administration of FF/UMEC/VI may produce paradoxical
bronchospasm that may be life-threatening.
Cardiovascular effects, such as cardiac arrhythmias e.g. atrial
fibrillation and tachycardia, may be seen after the administration
of muscarinic receptor antagonists and sympathomimetics, including
FF/UMEC/VI. Therefore, FF/UMEC/VI should be used with caution in
patients with unstable or life-threatening cardiovascular
disease.
Systemic steroid effects may occur with any inhaled
corticosteroid (ICS), particularly at high doses prescribed for
long periods. These effects are much less likely to occur than with
oral corticosteroids. Patients with moderate to severe hepatic
impairment receiving FF/UMEC/VI should be monitored for systemic
corticosteroid-related adverse reactions.
If a patient presents with symptoms such as blurred vision or
other visual disturbances, the patient should be considered for
referral to an ophthalmologist for evaluation of possible causes
which may include cataract, glaucoma or rare diseases such as
central serous chorioretinopathy (CSCR) which have been reported
after use of systemic and topical corticosteroids.
FF/UMEC/VI should be used with caution in patients with
convulsive disorders or thyrotoxicosis, in patients who are
unusually responsive to beta(2) -adrenergic agonists and in
patients with pulmonary tuberculosis or in patients with chronic or
untreated infection.
Consistent with its antimuscarinic activity, FF/UMEC/VI should
be used with caution in patients with urinary retention or with
narrow-angle glaucoma.
An increase in the incidence of pneumonia, including pneumonia
requiring hospitalisation, has been observed in patients with COPD
receiving ICS. There is some evidence of an increased risk of
pneumonia with increasing steroid dose but this has not been
demonstrated conclusively across all studies. There is no
conclusive clinical evidence for intra-class differences in the
magnitude of the pneumonia risk among ICS products.
Beta(2) -adrenergic agonists may produce significant
hypokalaemia in some patients, which has the potential to produce
adverse cardiovascular effects. The decrease in serum potassium is
usually transient, not requiring supplementation. No clinically
relevant effects of hypokalaemia were observed in clinical studies
with FF/UMEC/VI at the recommended therapeutic dose. Caution should
be exercised when FF/UMEC/VI is used with other medicinal products
that also have the potential to cause hypokalaemia.
Beta(2) -adrenergic agonists may produce transient hyperglycemia
in some patients. No clinically relevant effects on plasma glucose
were observed in clinical studies with FF/UMEC/VI at the
recommended therapeutic dose. Upon initiation of treatment with
FF/UMEC/VI, plasma glucose should be monitored more closely in
diabetic patients.
This medicinal product contains lactose. Patients with rare
hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take
FF/UMEC/VI.
The most frequently reported adverse reactions with FF/UMEC/VI
were nasopharyngitis (7%), headache (5%) and upper respiratory
tract infection (2%). Other common adverse reactions (reported with
a frequency of >=1/100 to <1/10) include: pneumonia,
pharyngitis, rhinitis, influenza, cough, arthralgia and back
pain.
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:
UK Media enquiries: Simon Steel +44 (0) 20 (London)
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/
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