FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending
19 September
2017
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Issued:
18 September 2017, London UK - LSE Announcement
Trelegy Ellipta approved as the first once-daily single inhaler
triple therapy for the treatment of appropriate patients with COPD
in the US
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:
|
|
|
|
UK
Media enquiries:
|
Simon
Steel
|
+44 (0)
20 8047 5502
|
(London)
|
|
David
Daley
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
|
|
US
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)
|
|
|
|
|
Analyst/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)
|
|
|
|
|
Innoviva, Inc. enquiries:
|
|
|
|
Investor
Relations:
|
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. 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/
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
|
GlaxoSmithKline plc
|
|
(Registrant)
|
|
|
Date: September
19, 2017
|
|
|
|
|
By: VICTORIA
WHYTE
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GlaxoSmithKline plc
|
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