GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva,
Inc. (NASDAQ: INVA) today announced positive headline results
from a non-inferiority lung function study, which demonstrated that
patients with well-controlled asthma were able to switch to the
once-daily Relvar® Ellipta® (fluticasone furoate/vilanterol, FF/VI)
100/25, an inhaled corticosteroid (ICS)/long-acting beta2 agonist
(LABA) combination, from the twice-daily Seretide® Accuhaler®
(fluticasone propionate /salmeterol, FP/SAL) 250/50, without
compromising their lung function.
Patients randomised to FF/VI taken once-daily maintained a lung
function comparable with those randomised to the twice-daily FP/SAL
[difference +19mL (95% CI: -11mL, +49mL], meeting the study’s
primary endpoint, based on the lower bound (-11ml) of the 95%
confidence interval falling above the non-inferiority margin of
-100mL.
A third treatment arm with fluticasone propionate (FP), ICS
monotherapy, was included to detect a lung function difference
between treatments. Results demonstrated statistically significant
differences in favour of the ICS/LABA combinations to FP
(p<0.001).
The incidences of on-treatment serious adverse events (SAEs) and
adverse events (AEs) of special interest were consistent with the
known safety profile of FF/VI, established in asthma patients from
other studies.
Eric Dube, SVP and Global Head of Respiratory Franchise, GSK
said: “At GSK we are constantly searching for ways in which we can
help patients better manage their asthma. In this positive study we
have demonstrated non-inferiority for once-daily Relvar versus
twice-daily Seretide on lung function. This gives us confidence
that for patients who struggle taking a twice-daily treatment
regimen, there may be a once-daily treatment option available,
providing greater physician choice to help patients.”
Mike Aguiar, CEO of Innoviva, Inc., added: “We believe the
results of this study are important for patients and physicians.
They provide additional evidence that patients with persistent
asthma, who are currently treated with a twice-daily ICS/LABA, in
this case Seretide, can experience a similar level of benefit in
lung function when treated with Relvar Ellipta, which only needs to
be taken once a day.”
The study design was agreed with European regulatory
authorities. GSK now intends to submit this data to the European
Medicines Agency (EMA).
Results from the study will be shared in future publications and
presentations.
Study Design
Following a 4-week open-label treatment period with FP/SAL
250/50 twice-daily, patients with well controlled asthma were
randomised to receive either FF/VI 100/25 once-daily, FP/SAL 250/50
twice-daily or FP 250 twice-daily in a double-blind, double-dummy
manner for 24 weeks at multiple centres in 12 countries.
The primary objective of the study was to demonstrate
non-inferiority of Relvar Ellipta 100/25 once-daily with Seretide
Accuhaler 250/50 twice-daily in adult and adolescent subjects 12
years of age and older with persistent bronchial asthma, well
controlled on twice-daily ICS/LABA. The endpoint for the study was
the change from baseline in clinic visit evening FEV1
(pre-brochodilator and pre-dose) at the end of the 24-week
treatment period.
To demonstrate the non inferiority of FF/VI vs FP/SAL the lower
limit of the 95% confidence interval for the mean difference in
change from baseline for evening FEV1 needed to be greater than the
pre defined margin of -100mL. This was to rule out the possibility
that FF/VI was more than -100mL inferior to FP/SAL.
About asthma
Asthma is a chronic lung disease that inflames and narrows the
airways. Asthma affects 358 million people worldwide. Despite
medical advances, more than half of patients continue to experience
poor control and significant symptoms impacting their daily
life.
The causes of asthma are not completely understood but likely
involve an interaction between a person’s genetic make-up and the
environment. Key risk factors are inhaled substances that provoke
allergic reactions or irritate the airways.
About Relvar Ellipta (fluticasone furoate +
vilanterol)
Relvar Ellipta is a once-daily dual combination treatment
comprising fluticasone furoate, an inhaled corticosteroid and
vilanterol, a long-acting beta2-agonist, in a single inhaler, the
Ellipta®.
Relvar Ellipta is indicated in Europe in the regular treatment
of patients aged 12 and over with asthma, where use of a
combination product (long-acting ß2–agonist, LABA, and inhaled
corticosteroid, ICS) is appropriate: Patients not adequately
controlled on both ICS and 'as-needed' short-acting ß2-agonist
(SABA).
Full EU prescribing information is available at: EU Prescribing
Information for Relvar Ellipta.
Important safety information for Relvar Ellipta in
Europe
FF/VI is contraindicated in patients with hypersensitivity
to either fluticasone furoate, vilanterol, or any of the
excipients.
FF/VI should not be used to treat acute asthma symptoms or an
acute exacerbation in COPD, for which a short-acting bronchodilator
is required. Increasing use of short-acting bronchodilators to
relieve symptoms indicates deterioration of control and patients
should be reviewed by a physician.
Patients should not stop therapy with FF/VI in asthma or COPD,
without physician supervision since symptoms may recur after
discontinuation.
Asthma-related adverse events and exacerbations may occur during
treatment with FF/VI. Patients should be asked to continue
treatment but to seek medical advice if asthma symptoms remain
uncontrolled or worsen after initiation of treatment with
FF/VI.
Paradoxical bronchospasm may occur with an immediate increase in
wheezing after dosing. This should be treated immediately with a
short-acting inhaled bronchodilator. FF/VI should be discontinued
immediately, the patient assessed and alternative therapy
instituted if necessary.
Cardiovascular effects, such as cardiac arrhythmias e.g.
supraventricular tachycardia and extrasystoles may be seen with
sympathomimetic medicinal products including FF/VI. Therefore
fluticasone furoate/vilanterol should be used with caution in
patients with severe cardiovascular disease.
For patients with moderate to severe hepatic impairment, the
92/22 mcg dose should be used and patients should be monitored
for systemic corticosteroid-related adverse reactions. FF/VI
184/22 mcg is not indicated for patients with COPD. There is
no additional benefit of the 184/22 mcg dose compared to the
92/22 mcg dose and there is a potential increased risk of
pneumonia and systemic corticosteroid-related adverse
reactions.
An increase in the incidence of pneumonia has been observed in
subjects with COPD receiving FF/VI. There was also an
increased incidence of pneumonias resulting in hospitalisation. In
some instances these pneumonia events were fatal.
The incidence of pneumonia in patients with asthma was common at
the higher dose. In a previous study of FF/VI in asthma the
incidence of pneumonia in patients with asthma taking FF/VI
184/22 mcg was numerically higher compared with those
receiving FF/VI 92/22 mcg or placebo.
Hyperglycaemia: There have been reports of increases in blood
glucose levels in diabetic patients and this should be considered
when prescribing to patients with a history of diabetes
mellitus.
Systemic effects may occur with any inhaled corticosteroid,
particularly at high doses prescribed for long periods. These
effects are much less likely to occur than with oral
corticosteroids. Possible systemic effects include Cushing’s
syndrome, Cushingoid features, adrenal suppression, decrease in
bone mineral density, growth retardation in children and
adolescents, cataract and glaucoma and more rarely, a range of
psychological or behavioural effects including psychomotor
hyperactivity, sleep disorders, anxiety, depression or aggression
(particularly in children).
FF/VI should be administered with caution in patients with
pulmonary tuberculosis or in patients with chronic or untreated
infections. Data from large asthma and COPD clinical trials were
used to determine the frequency of adverse reactions associated
with FF/VI.
Very common adverse reactions (occurring in >1/10 patients)
with FF/VI were headache and nasopharyngitis. Common adverse
reactions (occurring in >1/100 to <1/10 patients) were
pneumonia, upper respiratory tract infection, bronchitis,
influenza, candidiasis of mouth and throat, oropharyngeal pain,
sinusitis, pharyngitis, rhinitis, cough, dysphonia, abdominal pain,
arthralgia, back pain, fractures, and pyrexia and muscle
spasms..Extrasystoles were observed as an uncommon adverse reaction
(occurring in >1/1,000 to <1/100 patients). Rare adverse
reactions (occurring in >1/10,000 to < 1/1,000) were
hypersensitivity reactions (including anaphylaxis, angioedema, rash
and urticaria), anxiety, tremor, palpitations, tachycardia and
paradoxical bronchospasm. With the exception of pneumonia and
fractures, the safety profile was similar in patients with asthma
and COPD. During clinical studies, pneumonia and fractures were
more frequently observed in patients with COPD.
Relvar Ellipta is known as Breo Ellipta in the United
States. Breo Ellipta is licensed in the US for:
- The once-daily treatment of asthma in
patients aged 18 years and older.
Long-acting beta2-adrenergic agonists (LABA),
such as vilanterol, one of the active ingredients in Breo Ellipta,
increase the risk of asthma-related death. Available data from
controlled clinical trials suggest that LABA increase the risk of
asthma-related hospitalization in pediatric and adolescent
patients. Therefore, when treating patients with asthma, physicians
should only prescribe Breo Ellipta for patients not adequately
controlled on a long-term asthma control medication, such as an
inhaled corticosteroid, or whose disease severity clearly warrants
initiation of treatment with both an inhaled corticosteroid and a
LABA. Once asthma control is achieved and maintained, assess the
patient at regular intervals and step down therapy (e.g.,
discontinue Breo Ellipta) if possible without loss of asthma
control and maintain the patient on a long-term asthma control
medication, such as an inhaled corticosteroid. Do not use BREO
ELLIPTA for patients whose asthma is adequately controlled on low-
or medium-dose inhaled corticosteroids.
- Breo Ellipta is NOT indicated for the
relief of acute bronchospasm.
Full US prescribing information, including BOXED WARNING and
Medication Guide is available at us.gsk.com or US
Prescribing Information for Breo Ellipta.
About Seretide Accuhaler (fluticasone propionate +
salmeterol)
Seretide Accuhaler is a twice-daily dual combination treatment
comprising fluticasone propionate /salmeterol, in the Accuhaler
inhaler.
Seretide Accuhaler is indicated in Europe in the regular
treatment of patients aged 4 and over with asthma, where use of a
combination product (long-acting ß2–agonist, LABA, and inhaled
corticosteroid, ICS) is appropriate: Patients not adequately
controlled on both ICS and 'as-needed' short-acting ß2-agonist
(SABA); Patients already adequately controlled on both ICS and
LABA.
For the UK Summary of Product Characteristics (SmPC), please
visit:
https://www.medicines.org.uk/emc/medicine/2317/SPC/Seretide+100,+250,+500+Accuhaler
Important safety information for Seretide Accuhaler
Uses: Asthma: Regular treatment of asthma, where a
long-acting β2 agonist and inhaled corticosteroid is appropriate,
i.e. patients uncontrolled on inhaled corticosteroids and 'as
needed' short-acting inhaled bronchodilator or patients controlled
on inhaled corticosteroid and long-acting β2 agonist. Lowest
strength Seretide (salmeterol 25mcg/fluticasone propionate 50 mcg
and salmeterol 50mcg/fluticasone propionate 100 mcg) not
appropriate in severe asthma. COPD: Symptomatic treatment of
patients with COPD with a FEV1 <60% predicted normal
(pre-bronchodilator) and a history of repeated exacerbations, who
have significant symptoms despite regular bronchodilator
therapy.
Dosage and administration: Inhalation only. Asthma:
Adults and adolescents 12 years and over: Seretide Accuhaler - one
inhalation b.d. of: Seretide 100 (salmeterol 50 mcg/fluticasone
propionate 100 mcg) or Seretide 250 (salmeterol 50 mcg/fluticasone
propionate 250 mcg) or Seretide 500 (salmeterol 50 mcg/fluticasone
propionate 500 mcg), Seretide Evohaler – two puffs b.d. of:
Seretide 50 (salmeterol 25 mcg/fluticasone propionate 50 mcg) or
Seretide 125 (salmeterol 25 mcg/fluticasone propionate 125mcg) or
Seretide 250 (salmeterol 25 mcg/fluticasone propionate 250 mcg).
Children 4-11 years: Seretide 50 Evohaler (salmeterol 25
mcg/fluticasone propionate 50 mcg): two puffs b.d. Spacer
recommended for co-ordination. Seretide 100 Accuhaler (salmeterol
50 mcg/fluticasone propionate 100 mcg) one inhalation b.d.
Regularly review patients and reduce dose to lowest that maintains
effective symptom control. Where the control of symptoms is
maintained with the lowest strength of the combination, patients
may be prescribed an inhaled corticosteroid alone, or if a
long-acting β2 agonist is required, Seretide may be given once
daily. If rapid control of asthma in adults or adolescents with
moderate persistent asthma (defined as patients with daily
symptoms, daily rescue use and moderate to severe airflow
limitation) is essential, an initial dose of two inhalations b.d.
of Seretide 50 Evohaler (salmeterol 25 mcg/fluticasone propionate
50 mcg) or one inhalation b.d. of Seretide 100 Accuhaler
(salmeterol 50 mcg/fluticasone propionate 100 mcg) may be
considered on a short-term basis. Once control of asthma is
attained treatment should be regularly reviewed and stepped down.
Doubling the dose of all strengths of Seretide may be considered
when adult patients require additional short-term (up to 14 days)
inhaled corticosteroid therapy but this causes a small increase in
β-agonist-related adverse events. COPD: one inhalation b.d. of
Seretide 500 Accuhaler (salmeterol 50mcg/fluticasone propionate 500
mcg).
Contraindications: Hypersensitivity to the active
ingredients or to any of the excipients.
Precautions: Pulmonary tuberculosis, fungal, viral or
other infections of the airway, severe cardiovascular disorders,
heart rhythm abnormalities, diabetes mellitus, hypokalaemia and
thyrotoxicosis. Increased reporting of pneumonia and bronchitis in
patients with COPD receiving Seretide compared with placebo. If a
patient with severe COPD has experienced pneumonia, treatment with
Seretide should be re-evaluated. Paradoxical bronchospasm post
dose. Severe unstable asthma: Warn patients to seek medical advice
if short-acting inhaled bronchodilator use increases. Consider
increased inhaled/additional corticosteroid therapy. Acute
symptoms: Not for acute symptoms. Use short-acting inhaled
bronchodilator. Systemic effects: Systemic effects of inhaled
corticosteroids may occur, particularly at high doses for prolonged
periods, but much less likely than with oral corticosteroids. May
include Cushing’s syndrome, cushingoid features, adrenal
suppression, adrenal crisis, growth retardation in children and
adolescents, decrease in bone mineral density, cataract, glaucoma
and, more rarely, a range of psychological or behavioural effects
including psychomotor hyperactivity, sleep disorders, anxiety,
depression or aggression (particularly in children). Monitor height
of children on prolonged inhaled corticosteroid therapy. Tremor,
palpitations and headache, have been reported with β2 agonist
treatment. In asthma, therapy should be down titrated under
physician supervision to lowest effective dose and treatment should
not be abruptly stopped due to risk of exacerbation. Serious
asthma-related adverse events and exacerbations may occur during
treatment with Seretide. Patients should not be initiated on
Seretide during an exacerbation, or if they have significantly
worsening or acutely deteriorating asthma. Data from a large asthma
trial suggested patients of black African or Afro-Caribbean
ancestry were at increased risk of serious respiratory-related
events or deaths when using salmeterol. All patients should
continue treatment but seek medical advice if asthma symptoms
remain uncontrolled or worsen when initiated on Seretide or using
Seretide. In COPD cessation of therapy may also be associated with
decompensation and should be supervised by a physician. Transfer
from oral steroids: Special care needed. Consider appropriate
steroid therapy in stressful situations.
Drug interactions: Avoid beta-blockers. Avoid concomitant
administration of ketoconazole or other potent (e.g. itraconazole,
telithromycin, ritonavir) and moderate (erythromycin) CYP3A4
inhibitors unless benefits outweigh potential risk. β2 adrenergic
blockers may weaken or antagonise the effect of salmeterol.
Potentially serious hypokalaemia may result from β2 agonist
therapy. Particular caution is advised in acute severe asthma as
this effect may be potentiated by concomitant treatment with
xanthine derivatives, steroids and diuretics.
Pregnancy and lactation: Experience limited. Balance
risks against benefits.
Side effects: Very Common: headache, nasopharyngitis.
Common: candidiasis of the mouth and throat, hoarseness/dysphonia,
throat irritation, pneumonia, bronchitis, hypokalaemia, sinusitis,
contusions, traumatic fractures, arthralgia, myalgia, muscle
cramps. Uncommon: respiratory symptoms (dyspnoea), anxiety,
tremor, palpitations, tachycardia, angina pectoris, atrial
fibrillation, cutaneous hypersensitivity reactions, hyperglycaemia,
sleep disorders, cataract. Rare: angioedema, respiratory
symptoms (bronchospasm), anaphylactic reactions including
anaphylactic shock, Cushings syndrome, cushingoid features, adrenal
suppression, growth retardation in children and adolescents,
decreased bone mineral density, oesophageal candidiasis,
behavioural changes including psychomotor hyperactivity and
irritability (predominately in children), glaucoma, cardiac
arrhythmias and paradoxical bronchospasm. Not known: depression or
aggression (particularly in children). Paradoxical bronchospasm:
substitute alternative therapy.
Seretide Accuhaler is known as ADVAIR DISKUS in the United
States. ADVAIR DISKUS is licensed in the US for:
- The treatment of asthma in patients
aged 4 years and older.
Long-acting beta2-adrenergic agonists (LABA),
such as salmeterol, one of the active ingredients in ADVAIR DISKUS,
increase the risk of asthma-related death. Available data from
controlled clinical trials suggest that LABA increase the risk of
asthma-related hospitalization in pediatric and adolescent
patients. Therefore, when treating patients with asthma, physicians
should only prescribe ADVAIR DISKUS for patients not adequately
controlled on a long-term asthma control medication, such as an
inhaled corticosteroid, or whose disease severity clearly warrants
initiation of treatment with both an inhaled corticosteroid and a
LABA. Once asthma control is achieved and maintained, assess the
patient at regular intervals and step down therapy (e.g.,
discontinue ADVAIR DISKUS) if possible without loss of asthma
control and maintain the patient on a long-term asthma control
medication, such as an inhaled corticosteroid. Do not use ADVAIR
DISKUS for patients whose asthma is adequately controlled on low-
or medium-dose inhaled corticosteroids.
- ADVAIR DISKUS is NOT indicated for the
relief of acute bronchospasm.
Full US prescribing information, including BOXED WARNING and
Medication Guide is available at us.gsk.com or US
Prescribing Information for Advair Diskus.
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.
RELVAR®, BREO®, ELLIPTA®, SERETIDE®, ACCUHALER®, ADVAIR®,
DISKUS® are trademarks of the GlaxoSmithKline 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 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, 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, 2015 and
Quarterly Report on Form 10-Q for the quarter ended September 30,
2016, which are on file with the U.S. Securities and Exchange
Commission (SEC) and available on the SEC's website at www.sec.gov.
Additional factors may be described in those sections of Innoviva's
Annual Report on Form 10-K for the year ended December 31, 2016, to
be filed with the SEC in the first quarter of 2017.. 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
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