TIDMGSK
RNS Number : 9137K
GlaxoSmithKline PLC
30 June 2014
Issued: Monday 30 June 2014, London UK & South San
Francisco, CA, USA - LSE Announcement
GSK and Theravance announce submission to US regulatory
authorities for fluticasone furoate/vilanterol in asthma
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc.
(NASDAQ: THRX) today announced the submission of a supplemental New
Drug Application (sNDA) to the US Food and Drug Administration
(FDA) for a fixed dose combination of the inhaled corticosteroid,
fluticasone furoate and the long-acting beta(2) agonist, vilanterol
(FF/VI) as a once-daily treatment for asthma in patients aged 12
years and older, with the brand name of Breo(R) Ellipta(R) .
The sNDA is seeking approval for two dose regimens, 100/25mcg
and 200/25mcg, administered once daily using the Ellipta dry powder
inhaler.
Today's filing is based upon data generated from the
comprehensive clinical development programme for FF/VI in asthma.
The clinical development programme comprised 48 clinical
pharmacology studies in 1,328 subjects and 23 clinical studies in
12,051 patients with asthma, including the Phase III efficacy and
safety study of FF/VI reported in December 2013.
About asthma
Asthma is a chronic lung disease that inflames and narrows the
airways, causing recurring periods of wheezing, chest tightness,
shortness of breath and coughing which often occurs at night or
early in the morning.(1)
Despite medical advances, more than half of patients continue to
experience poor control and significant symptoms.(2)
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. These include allergens
such as dust mites and pets.(1)
About Breo Ellipta in the US
FF/VI 100/25mcg was approved by the US Food and Drug
Administration under the brand name Breo Ellipta in May 2013 as a
prescription medication for the long-term, once-daily, maintenance
treatment of airflow obstruction and for reducing exacerbations in
patients with chronic obstructive pulmonary disease (COPD),
including chronic bronchitis and/or emphysema. Breo Ellipta is not
indicated for the relief of acute bronchospasm or the treatment of
asthma in the US.
Full US prescribing information, including BOXED WARNING and
Medication Guide is available at us.gsk.com or US Prescribing
Information for Breo Ellipta.
Important Safety Information (ISI) for Breo Ellipta (FF/VI) in
COPD in the US
The following ISI is based on the Highlights section of the U.S.
Prescribing Information for Breo Ellipta (fluticasone furoate 100
mcg / vilanterol 25 mcg) for the maintenance treatment of airflow
obstruction in patients with COPD and to reduce exacerbations of
COPD in patients with a history of exacerbations. Please consult
the full Prescribing Information for all the labeled safety
information for Breo Ellipta.
Long-acting beta(2) -adrenergic agonists (LABAs), such as
vilanterol, one of the active ingredients in Breo Ellipta, increase
the risk of asthma-related death. A placebo-controlled trial with
another LABA (salmeterol) showed an increase in asthma-related
deaths in subjects receiving salmeterol. This finding with
salmeterol is considered a class effect of all LABAs, including
vilanterol. In the US, the safety and efficacy of Breo Ellipta in
patients with asthma have not been established and therefore Breo
Ellipta is not indicated for the treatment of asthma.
Breo Ellipta is contraindicated in patients with severe
hypersensitivity to milk proteins or who have demonstrated
hypersensitivity to either fluticasone furoate, vilanterol, or any
of the excipients.
Breo Ellipta should not be initiated in patients during rapidly
deteriorating or potentially life-threatening episodes of COPD, or
as rescue therapy for the treatment of acute episodes of
bronchospasm. Acute symptoms should be treated with an inhaled,
short-acting beta(2) -agonist.
Breo Ellipta should not be used more often than recommended, at
higher doses than recommended, or in conjunction with other
medications containing LABAs, as an overdose may result.
Oropharyngeal candidiasis has occurred in patients treated with
Breo Ellipta. Patients should rinse their mouth with water without
swallowing after inhalation to help reduce this risk.
An increase in the incidence of pneumonia has been observed in
subjects with COPD receiving the fluticasone furoate/vilanterol
combination, including Breo Ellipta100 mcg/25 mcg, in clinical
trials. There was also an increased incidence of pneumonias
resulting in hospitalization. In some incidences these pneumonia
events were fatal.
Patients who use corticosteroids are at risk for potential
worsening of existing tuberculosis; fungal, bacterial, viral, or
parasitic infections; or ocular herpes simplex. A more serious or
even fatal course of chickenpox or measles may occur in susceptible
patients.
Particular care is needed for patients who have been transferred
from systemically active corticosteroids to inhaled corticosteroids
because deaths due to adrenal insufficiency have occurred in
patients with asthma during and after transfer from systemic
corticosteroids to less systemically available inhaled
corticosteroids.
Hypercorticism and adrenal suppression may occur with very high
dosages or at the regular dosage of inhaled corticosteroids in
susceptible individuals.
Caution should be exercised when considering the
co-administration of Breo Ellipta with long--term ketoconazole and
other known strong CYP3A4 inhibitors because increased systemic
corticosteroid and cardiovascular adverse effects may occur.
As with other inhaled medicines, Breo Ellipta can produce
paradoxical bronchospasm which may be life-threatening. Vilanterol,
the LABA in Breo Ellipta, can produce clinically significant
cardiovascular effects in some patients as measured by increases in
pulse rate, systolic or diastolic blood pressure, and also cardiac
arrhythmias. Decreases in bone mineral density have been observed
with long-term administration of products containing inhaled
corticosteroids, as have glaucoma, increased intraocular pressure,
and cataracts.
Breo Ellipta should be used with caution in patients with
convulsive disorders, thyrotoxicosis, diabetes mellitus,
ketoacidosis, and in patients who are unusually responsive to
sympathomimetic amines.
Beta-adrenergic agonist medicines may produce significant
hypokalemia in some patients. Beta-adrenergic agonist medicines may
produce transient hyperglycemia in some patients.
The most common adverse reactions (>=3% and more common than
in placebo) reported in two 6-month clinical trials with Breo
Ellipta (and placebo) were nasopharyngitis, 9% (8%); upper
respiratory tract infection, 7% (3%); headache, 7% (5%); and oral
candidiasis, 5% (2%). In addition to the events reported in the
6-month studies, adverse reactions occurring in >=3% of the
subjects treated with Breo Ellipta in two 1-year studies included
COPD, back pain, pneumonia, bronchitis, sinusitis, cough,
oropharyngeal pain, arthralgia, hypertension, influenza,
pharyngitis, diarrhea, peripheral edema, and pyrexia.
RELVAR(R) , BREO(R) , and ELLIPTA(R) are trade marks of the
GlaxoSmithKline group of companies.
V A Whyte
Company Secretary
30 June 2014
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.
Theravance, Inc., A Royalty Management Company - is focused on
maximizing the potential value of the respiratory assets partnered
with Glaxo Group Limited (GSK), including RELVAR(R) /BREO(R)
ELLIPTA(R) and ANORO(TM) ELLIPTA(R) , with the intention of
providing capital returns to stockholders. Under the Long-Acting
Beta(2) Agonist (LABA) Collaboration Agreement with GSK, Theravance
is eligible to receive the associated royalty revenues from
RELVAR(R)/BREO(R) ELLIPTA(R) (fluticasone furoate/vilanterol,
"FF/VI"), ANORO(TM) ELLIPTA(R) (umeclidinium bromide/vilanterol,
"UMEC/VI") and if approved and commercialized, VI monotherapy.
Theravance is also entitled to a 15% economic interest in any
future payments made by GSK relating to the combination of
UMEC/VI/FF and the Bifunctional Muscarinic Antagonist-Beta(2)
Agonist (MABA) program, as monotherapy and in combination with
other therapeutically active components, such as an inhaled
corticosteroid, and any other product or combination of products
that may be discovered and developed in the future under its LABA
Collaboration Agreement with GSK (other than RELVAR(R) /BREO(R)
ELLIPTA(R) , ANORO(TM) ELLIPTA(R) and VI monotherapy). For more
information, please visit Theravance's web site at
www.thrxinc.com.
References
(1.) Global Initiative for Asthma. Pocket Guide for asthma
management and prevention. Updated 2014.
(2.) Demoly et al. Eur Respir Rev. 2012 Mar 1;21(123):66-74.
doi: 10.1183/09059180.00008111.
GSK enquiries:
UK Media enquiries: David Mawdsley +44 (0) 20 8047 (London)
5502
Simon Steel +44 (0) 20 8047 (London)
5502
David Daley +44 (0) 20 8047 (London)
5502
Catherine Hartley +44 (0) 20 8047 (London)
5502
Sarah Spencer +44 (0) 20 8047 (London)
5502
US Media enquiries: Stephen Rea +1 215 751 4394 (Philadelphia)
Melinda Stubbee +1 919 483 2510 (North Carolina)
Mary Anne Rhyne +1 919 483 0492 (North Carolina)
Sarah Alspach +1 202 715 1048 (Washington)
Jennifer Armstrong +1 215 751 5664 (Philadelphia)
Analyst/Investor Ziba Shamsi +44 (0) 20 8047 (London)
enquiries: 5543
Kirsty Collins +44 (0) 20 8047 (London)
(SRI & CG) 5534
Tom Curry + 1 215 751 5419 (Philadelphia)
Gary Davies +44 (0) 20 8047 (London)
5503
James Dodwell +44 (0) 20 8047 (London)
2406
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Lucy Singah +44 (0) 20 8047 (London)
2248
Theravance, Inc.
enquiries:
Investor Relations Michael W. Aguiar +1 650 238 9640 (S. San Francisco)
investor.relations@thrxinc.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 2013.
Theravance 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. Theravance 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. Examples of such statements include
statements relating to: the strategies, plans and objectives of the
company following the separation, the timing, manner, amount and
planned growth of anticipated potential capital returns to
stockholders (including without limitation statements concerning
the intention to initiate a cash dividend in the third quarter of
2014, expectations of future cash dividend growth and the potential
for future share repurchases), the status and timing of clinical
studies, data analysis and communication of results, the potential
benefits and mechanisms of action of product candidates,
expectations for product candidates through development and
commercialization, the timing of seeking regulatory approval of
product candidates, and projections of revenue, expenses and other
financial items. These statements are based on the current
estimates and assumptions of the management of Theravance 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 Theravance 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 include, among
others, risks related to: delays or difficulties in commencing or
completing clinical studies, the potential that results from
clinical or non-clinical studies indicate product candidates are
unsafe or ineffective, dependence on third parties to conduct its
clinical studies, delays or failure to achieve and maintain
regulatory approvals for product candidates, and risks of
collaborating with third parties to discover, develop and
commercialize products. Other risks affecting Theravance are
described under the heading "Risk Factors" contained in
Theravance's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on May 7, 2014 and the
risks discussed in Theravance's other periodic filings with the
SEC. Given these uncertainties, you should not place undue reliance
on these forward-looking statements. Theravance assumes no
obligation to update its forward-looking statements. (THRX-G)
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
This information is provided by RNS
The company news service from the London Stock Exchange
END
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