Blueprint
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 26 January
2018
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:
26 January 2018 London UK - LSE Announcement
GSK announces CHMP positive opinion 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 Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP)
has issued a positive
opinion recommending a label update for the use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI), an inhaled
corticosteroid (ICS) / long-acting b2-agonist (LABA) combination, in patients whose asthma is already adequately
controlled on both an inhaled corticosteroid and long-acting
b2-agonist.
Jonathan Sweeting, SVP and Global Head of Respiratory Franchise
GSK, said: "There are many asthma patients in Europe who,
despite being adequately controlled on a twice-daily ICS/LABA, are
still experiencing symptoms or problems with their
asthma.
We are
very excited about achieving this CHMP positive opinion which, if
approved, provides an additional option for physicians, who can
prescribe once-daily Relvar Ellipta for their asthma
patients".
The Type II variation regulatory submission 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.
Mike Aguiar, CEO of Innoviva, Inc., added: "Asthma is a persistent
condition; management guidelines recommend treatment be
individualized until control has been achieved. Today's positive
opinion supports once-daily Relvar Ellipta as an important option
for doctors and patients in effectively managing
asthma."
A
positive CHMP opinion is one of the final steps before marketing
authorisation is updated by the European Commission. A final
decision is anticipated towards the end of the first quarter of
2018.
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
b2-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 b2-agonist, LABA, and inhaled corticosteroid, ICS)
is appropriate: Patients not adequately controlled on both ICS and
'as-needed' short-acting b2-agonist
(SABA).
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 b2-agonist, LABA, and inhaled corticosteroid, ICS)
is appropriate: Patients not adequately controlled on both ICS and
'as-needed' short-acting b2-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 b2 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 b2 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 b2 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 b-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 b2 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. b2 adrenergic
blockers may weaken or antagonise the effect of salmeterol.
Potentially serious hypokalaemia may result from
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 - 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:
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UK
Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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David
Daley
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Sarah
Alspach
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+1 202
715 1048
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(Washington,
DC)
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Karen
Hagens
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+1 919
483 2863
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(North
Carolina)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
208 047 5194
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(London)
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Tom
Curry
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+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Innoviva, Inc. enquiries:
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Investor
Relations:
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Eric
d'Esparbes
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+1
(650) 238-9605
investor.relations@inva.com
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(Brisbane,
Calif.)
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GSK cautionary statement regarding forward-looking
statementsGSK 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.
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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, 2016 and Quarterly Report on Form 10-Q for the
quarter ended September 30, 2017, 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, 2017, to be filed with the SEC in the first
quarter of 2018. 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
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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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.
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GlaxoSmithKline plc
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(Registrant)
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Date: January
26, 2018
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By: VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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