TIDMGSK
RNS Number : 0866H
GlaxoSmithKline PLC
08 March 2018
Issued: 8 March 2018 London UK - LSE Announcement
GSK announces positive EU approval for labelling update to
Relvar Ellipta in patients with asthma
GlaxoSmithKline plc (LSE/NYSE:GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced that the European Commission has approved a
label update for the use of once-daily Relvar Ellipta (fluticasone
furoate/vilanterol, FF/VI), an inhaled corticosteroid (ICS) /
long-acting <BETA>(2) -agonist (LABA) combination, in
patients whose asthma is already adequately controlled on both an
inhaled corticosteroid and long-acting <BETA>(2)
-agonist.
The Type II variation regulatory approval has been supported by
data from a non-inferiority lung function study, which demonstrated
that patients with adequately controlled asthma were able to switch
to the once-daily FF/VI 100/25, from the twice-daily Seretide
Accuhaler (fluticasone propionate /salmeterol, FP/SAL) 250/50,
without compromising their lung function. No new safety signals
were identified and the adverse event data were consistent with the
known safety profile for FF/VI established in patients with
asthma.
Jonathan Sweeting, SVP and Head of Global Respiratory Franchise
GSK, said: Patients with asthma can continue to experience symptoms
despite being adequately controlled and these symptoms can impact
their lives. This label update gives doctors the option of
switching appropriate patients from their current ICS/LABA to
once-daily Relvar Ellipta."
Dr. Theodore J. Witek Jr., Senior Vice President and Chief
Scientific Officer of Innoviva, Inc., added: "The evidence
supporting this regulatory update means doctors can be confident
that patients taking once-daily Relvar Ellipta will experience
comparable benefit in lung function and safety profile, as with a
twice-daily ICS/LABA. We welcome this approval, which signifies an
important milestone for Relvar Ellipta."
The updated marketing authorisation by the European Commission
will be reflected in the label for Relvar Ellipta for countries in
the European Union.
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 <BETA>(2) -agonist, in a single
inhaler, the Ellipta(R) .
Relvar Ellipta is indicated in Europe for the regular treatment
of asthma in adults and adolescents aged 12 years and older where
use of a combination medicinal product (long-acting beta(2)
-agonist, and inhaled corticosteroid) is appropriate: patients not
adequately controlled with inhaled corticosteroids and 'as-needed'
inhaled short acting beta(2) -agonists; patients already adequately
controlled on both inhaled corticosteroid and long-acting beta(2)
-agonist.
Full EU prescribing information is available at: EU Prescribing
Information for Relvar Ellipta.
GSK's commitment to respiratory disease
GSK has led the way in developing innovative medicines to
advance the management of asthma and COPD for nearly 50 years. Over
the last four years we have launched six innovative medicines
responding to continued unmet patient need, despite existing
therapies. This is an industry leading portfolio in breadth, depth
and innovation, developed to reach the right patients, with the
right treatment.
We remain at the cutting-edge of scientific research into
respiratory medicine, working in collaboration with patients and
the scientific community to offer innovative medicines aimed at
helping to treat patients' symptoms and reduce the risk of their
disease worsening. While respiratory diseases are clinically
distinct, there are important pathophysiological features that span
them, and our ambition is to have the most comprehensive portfolio
of medicines to address a diverse range of respiratory diseases. To
achieve this, we are focusing on targeting the underlying
disease-driving biological processes to develop medicines with
applicability across multiple respiratory diseases. This approach
requires extensive bioinformatics, data analytic capabilities,
careful patient selection and stratification by phenotype in our
clinical trials.
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.
Full US prescribing information 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 <BETA>(2) -agonist, LABA,
and inhaled corticosteroid, ICS) is appropriate: Patients not
adequately controlled on both ICS and 'as-needed' short-acting
<BETA>(2) -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
<BETA>(2) 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 <BETA>(2) 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
<BETA>(2) 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
<BETA>-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 <BETA>(2)
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. <BETA>(2)
adrenergic blockers may weaken or antagonise the effect of
salmeterol. Potentially serious hypokalaemia may result from b(2)
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.
Full US prescribing information, is available at us.gsk.com or
US Prescribing Information for Advair Diskus.
GSK - a science-led global healthcare company with a special
purpose: to help people do more, feel better, 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 medicines
to patients in areas of unmet need by leveraging its significant
expertise in the development, commercialization and financial
management of bio-pharmaceuticals to maximize the potential of its
respiratory assets partnered with Glaxo Group Limited (GSK),
including RELVAR(R) /BREO(R) ELLIPTA(R) , ANORO(R) ELLIPTA(R) , and
TRELEGY(R) ELLIPTA(R). Under the agreement with GSK, Innoviva is
eligible to receive associated royalty revenues from RELVAR(R)
/BREO(R) ELLIPTA(R) , and ANORO(R) ELLIPTA(R) . 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 TRELEGY(R) ELLIPTA(R). For more
information, please visit Innoviva's website at www.inva.com.
GSK enquiries:
Simon Steel +44 (0) 20 (London)
8047 5502
David Daley +44 (0) 20 (London)
8047 5502
US Media enquiries: Sarah Spencer +1 215 751 (Philadelphia)
3335
Karen Hagens +1 919 483 (North Carolina)
2863
Analyst/Investor Sarah Elton-Farr +44 (0) 20 (London)
enquiries: 8047 5194
Tom Curry + 1 215 751 (Philadelphia)
5419
Gary Davies +44 (0) 20 (London)
8047 5503
James Dodwell +44 (0) 20 (London)
8047 2406
Jeff McLaughlin +1 215 751 (Philadelphia)
7002
Innoviva, Inc.
enquiries:
Investor Relations: Eric d'Esparbes +1 (650) 238-9640 (Brisbane,
investor.relations@inva.com 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 Relvar Ellipta.
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, 2017, which is on file with the U.S. 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:
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Brentford, Middlesex
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This information is provided by RNS
The company news service from the London Stock Exchange
END
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