LONDON, Sept. 18, 2017 /PRNewswire/ -- GlaxoSmithKline
plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today
announced that the US Food and Drug Administration (FDA) has
approved once-daily, single inhaler triple therapy fluticasone
furoate/umeclidinium/vilanterol (FF/UMEC/VI), under the brand name
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.
Trelegy Ellipta 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. It is the first once-daily
product approved in the US that combines three active molecules in
a single inhaler for the maintenance treatment of appropriate
patients with COPD. The FDA-approved strength is FF/UMEC/VI
100/62.5/25 mcg.
Eric Dube, SVP & Head, GSK
Global Respiratory Franchise, said, "COPD is a progressive disease
that can worsen over time, and represents a significant burden to
patients and healthcare systems. The approval of Trelegy Ellipta,
and the addition of a once-daily single inhaler triple therapy to
our portfolio of respiratory medicines, is an important milestone
for GSK that builds on our long heritage in this area."
Mike Aguiar, CEO of Innoviva,
Inc., added, "This approval represents a significant therapeutic
convenience for those appropriate patients already on Breo Ellipta,
that require additional bronchodilation or for those patients
already on a combination of Breo Ellipta and Incruse Ellipta.
Trelegy Ellipta is the latest development in our collaboration with
GSK and is testament to our ongoing efforts to advance respiratory
medicine."
Following this approval by the FDA, Trelegy Ellipta will be
available in the US shortly.
Regulatory applications have been submitted and are undergoing
assessment in a number of other countries, including the European
Union, Australia and Canada.
On 15 September 2017, the European
Medicines Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP) issued a positive opinion recommending marketing
authorisation for FF/UMEC/VI as 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. Positive Opinion is one of the final
steps before marketing authorisation is granted by the European
Commission. The proposed trade name Trelegy Ellipta remains subject
to regulatory approval in Europe.
FF/UMEC/VI is not licensed as a single inhaler triple therapy
anywhere outside of the US.
About COPD
COPD is a common but serious lung disease
that is thought to affect 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 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 beta2-adrenergic agonist, in a single inhaler, the
Ellipta.
Full US Prescribing Information, including BOXED WARNING and
Medication Guide will be available soon at: us.gsk.com.
Prior to the label being posted online, a copy of the label 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.
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 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.
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®/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
enquiries:
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UK Media
enquiries:
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Simon
Steel
|
+44 (0) 20 8047
5502
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(London)
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David
Daley
|
+44 (0) 20 8047
5502
|
(London)
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US Media
enquiries:
|
Karen
Hagens
|
+1 919 483
2863
|
(North
Carolina)
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Juan Carlos
Molina
|
+1 919 483
0471
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(North
Carolina)
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Sarah
Spencer
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+1 215 751
3335
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(Philadelphia)
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Analyst/Investor
enquiries:
|
Sarah
Elton-Farr
|
+44 (0) 20 8047
5194
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(London)
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Tom Curry
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+ 1 215 751
5419
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(Philadelphia)
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Gary
Davies
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+44 (0) 20 8047
5503
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(London)
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James
Dodwell
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+44 (0) 20 8047
2406
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(London)
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Jeff
McLaughlin
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+1 215 751
7002
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(Philadelphia)
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Innoviva, Inc.
enquiries:
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Investor
Relations:
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Eric
d'Esparbes
|
+1 (650)
238-9605
investor.relations@inva.com
|
(Brisbane,
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 June 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.
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Registered
Office:
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Brentford,
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TW8 9GS
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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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content:http://www.prnewswire.com/news-releases/trelegy-ellipta-approved-as-the-first-once-daily-single-inhaler-triple-therapy-for-the-treatment-of-appropriate-patients-with-copd-in-the-us-300521643.html
SOURCE GlaxoSmithKline plc; Innoviva, Inc.