GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced that the Japanese Ministry of Health, Labour
and Welfare (MHLW) has approved Relvar® Ellipta® (fluticasone
furoate / vilanterol 100/25 mcg) for the relief of various symptoms
with chronic obstructive pulmonary disease (chronic bronchitis,
pulmonary emphysema) (in the case where concurrent use of inhaled
corticosteroid and long-acting inhaled beta2 agonist is
required).
Relvar is a combination of the inhaled corticosteroid (ICS),
fluticasone furoate ‘FF’, and the long-acting beta2 agonist
(LABA), vilanterol ‘VI’. The approved dose of FF/VI in chronic
obstructive pulmonary disease (COPD) is 100/25 mcg administered
once-daily using the Ellipta dry powder inhaler (DPI). Relvar
Ellipta has been approved in Japan for the treatment of asthma
since 2013 in two strengths – 100/25 mcg and 200/25 mcg.
Eric Dube, SVP & Head, GSK Global Respiratory Franchise,
said, “COPD affects people in different ways, and a range of
treatments are needed so that physicians can determine the right
treatment for the right patient. GSK has over 45 years of
experience in delivering medicines that meet the individual needs
of patients with respiratory diseases. We are delighted with this
approval of Relvar Ellipta, our third COPD treatment to gain
marketing authorisation in Japan in under three years, and believe
it will be an important new option for appropriate patients with
COPD, as well as those with asthma.”
“The approval of Relvar Ellipta for COPD will provide Japanese
physicians with a new, important once-daily, inhaled treatment
option for appropriate patients,” said Mike Aguiar, CEO of
Innoviva, Inc. “This represents yet another significant milestone
in the respiratory partnership between Innoviva and GSK.”
The MHLW assessment of FF/VI was based on data from the global
clinical development programme, as well as results from a global
phase III study (study 200820) which was conducted to provide
efficacy and safety data for the combination, FF/VI, compared with
its component, VI, specifically in Japanese patients with COPD.
About Relvar Ellipta
Relvar Ellipta (FF/VI) was approved for the treatment of
bronchial asthma (in cases where concurrent use of inhaled
corticosteroid and long-acting inhaled beta2 agonist is
required) in Japan in 2013.
Relvar Ellipta is also known as Breo Ellipta in some other
markets, including the US.
About COPD
COPD is a disease of the lungs that includes chronic bronchitis,
emphysema or both. COPD is characterised by obstruction to airflow
that interferes with normal breathing. COPD is thought to affect
approximately 8.6% of the population aged over 40 in Japan.i
Long-term exposure to lung 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.ii
Important Safety Information for Relvar Ellipta
(FF/VI)
The following Important Safety Information (ISI) is based on a
summary of the Japanese Drug Information for Relvar Ellipta. Please
consult the full Drug Information for all the labeled safety
information for Relvar Ellipta.
FF/VI is contraindicated in patients with hypersensitivity to
fluticasone furoate, vilanterol, or any of the excipients and in
patients with infections or deep mycosis against which there is no
effective anti-bacterial agent (symptoms may be exacerbated due to
steroid effects).
Relvar Ellipta is not indicated for acute treatment of COPD
exacerbation. Because FF/VI is not intended for immediate relief of
symptoms or COPD exacerbations that have occurred, the product
should not be used to relieve acute symptoms. Another appropriate
drug such as short-acting inhaled beta2 agonist (e.g. inhaled
salbutamol sulphate) should be used for relief of acute symptoms or
COPD exacerbation.
FF/VI should be administered with caution in patients with
tuberculosis or infections, patients with severe cardiac disease,
and patients with hepatic impairment.
Patients should be cautioned to visit a medical institution as
soon as possible to seek medical treatment if they notice
increasing use or insufficient effect of the short-acting inhaled
beta2 agonist because asthma or COPD management may be
inadequate.
Patients should be instructed not to stop inhaling FF/VI on
their own since symptoms may be exacerbated after discontinuation
of the product.
As with other inhaled drugs, paradoxical bronchospasm may occur
with an increase in wheezing after inhalation of FF/VI. In such a
case, FF/VI should be discontinued immediately, and treatment with
a short-acting inhaled bronchodilator should be given. The patient
should be assessed and alternative therapy should be considered if
necessary.
Asthma-related events and asthma exacerbations may occur during
treatment with FF/VI. Patients should be instructed not to stop
inhaling FF/VI on their own but to seek medical advice if asthma
symptoms remain uncontrolled or are exacerbated after initiation of
treatment with the product.
Systemic effects (including Cushing’s syndrome, Cushingoid
symptoms, adrenal suppression, growth retardation in children,
decrease in bone mineral density, cataract, and glaucoma) may occur
with inhaled steroids although these effects are less likely than
with systemic steroids. Therefore, inhaled steroids should be used
at the lowest dose to effectively control asthma for each patient.
Particularly, patients who are treated at high doses for long
periods should be monitored with regular examinations; in case
systemic effects occur, appropriate measures should be taken while
monitoring the patient’s asthmatic symptoms.
It has been reported in a global clinical study and overseas
clinical studies in patients with chronic obstructive pulmonary
disease that the incidence of pneumonia showed a FF/VI
dose-dependent increase. Caution should be exercised when FF/VI is
administered to patients who are generally at potentially high risk
for developing pneumonia.
Caution should be exercised when considering the
coadministration of FF/VI with long-term ketoconazole and other
known strong CYP3A4 inhibitors because increased systemic
corticosteroid and cardiovascular adverse effects may
occur. Caution should also be exercised when considering the
coadministration of FF/VI with beta-blockers which may weaken the
effect of FF/VI.
Adverse reactions (asthma): In three global phase III clinical
studies, adverse reactions including laboratory abnormalities were
reported in 100 (7.1%) of a total of 1,407 patients (including 61
Japanese patients) treated with FF/VI. The common adverse reactions
were dysphonia and oral candidiasis reported in 19 (1.4%) and 12
(0.9%) patients, respectively. Of 61 Japanese patients, adverse
reactions including laboratory abnormalities were reported in 7
patients (11.5%). The common adverse reactions were dysphonia and
oral candidiasis reported in 3 (4.9%) and 2 (3.3%) patients,
respectively (at the time of approval).
In a Japanese long-term administration study, adverse reactions
including laboratory abnormalities were reported in 40 (26.1%) of a
total of 153 patients treated with FF/VI. The common adverse
reactions were oral candidiasis and dysphonia reported in 16
(10.5%) and 10 (6.5%) patients, respectively (at the time of
approval).
Adverse reactions (COPD): In three global phase III clinical
studies and two overseas phase III clinical studies, adverse
reactions including laboratory abnormalities were reported in 196
(9.7%) of a total of 2022 patients treated with FF/VI. The most
frequent adverse reactions were oral candidiasis reported in 77
(3.8%), oropharyngeal candidiasis reported in 22 (1.1%), pneumonia
reported in 8 (0.4%), and dysphonia reported in 8 (0.4%) (at the
time of approval).
In a Japanese long-term administration study, adverse reactions
including laboratory abnormalities were reported in 12 (20.0%) of a
total of 60 patients treated with Relvar Ellipta. The most frequent
adverse reactions were dysphonia and decreased urine free-cortisol
reported in 6 (10.0%) and 2 (3.3%) patients, respectively (at the
time of approval).
An anaphylactic reaction may occur (incidence unknown). Patients
treated with Relvar Ellipta should be monitored closely, and if an
abnormality is observed, the treatment should be discontinued and
appropriate measures should be taken.
Since pneumonia may be developed (incidence 0.5%), patients
should be observed carefully, and in case abnormality is detected,
an appropriate treatment should be given.
Japanese Drug Information will be available soon at
http://glaxosmithkline.co.jp/healthcare/. 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
“GlaxoSmithKline Inquiries” section at the end of this
document.
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® and,
if approved and commercialized, VI monotherapy, as well. 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.
RELVAR®, BREO® and ELLIPTA® are trademarks of the
GlaxoSmithKline group of companies.
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.
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
'Risk factors' in the company's Annual Report on Form 20-F for
2015.
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. 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, 2015 and
Quarterly Report on Form 10-Q for the quarter ended September 30,
2016, 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)
_____________________i Fukuchi Y. 2004. COPD in Japan: the
Nippon COPD Epidemiology study. Respirology. 2004
Nov;9(4):458-65.ii National Heart Lung and Blood Institute. Who is
at risk for COPD? Accessed March 2014. Available at:
https://www.nhlbi.nih.gov/health/health-topics/topics/copd/atrisk.html
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