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 patients who are on 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 (for
effects on symptom control see section 5.1). This 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 patients who are on 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.
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. 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/
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version on businesswire.com: http://www.businesswire.com/news/home/20170918006514/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:Karen Hagens, +1 919 483 2863 (North Carolina)Juan
Carlos Molina, +1 919 483 0471 (North Carolina)Sarah Spencer, +1
215 751 3335 (Philadelphia)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.)investor.relations@inva.com
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