TIDMGSK
RNS Number : 9714H
GlaxoSmithKline PLC
19 March 2015
Issued: 19 March 2015, London, UK, and South San Francisco, CA,
USA
GSK and Theravance announce outcome of US FDA Advisory Committee
on BREO(R) ELLIPTA(R) in asthma
GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ:
THRX) today announced the outcome of the joint meeting of the
Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk
Management Advisory Committee of the United States (US) Food and
Drug Administration (FDA) regarding the supplemental New Drug
Application (sNDA) for BREO(R) ELLIPTA(R) (fluticasone
furoate/vilanterol [FF/VI]) as a once-daily inhaled treatment for
asthma in patients aged 12 years and older.
The FDA Advisory Committee voted that the efficacy and safety
data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma
support approval in adults 18 years of age and older (16 for, 4
against). The Committee voted that the efficacy data provides
substantial evidence of a clinically meaningful benefit in adults
(18 for, 2 against) and that the safety in this population has been
adequately demonstrated (17 for, 3 against).
The Committee voted against approval for the proposed indication
in 12-17 year olds (2 for, 18 against)*. The Committee voted that
the efficacy data was not sufficient to demonstrate the benefit (4
for, 16 against) and the safety (1 for, 19 against) has not been
adequately demonstrated in this sub-population.
The Committee recommended that a large LABA safety trial with
FF/VI should be required in adults (13 yes, 7 no) and in 12-17 year
olds (17 yes, 2 no and 1 no-vote), similar to the ongoing LABA
safety trials being conducted as an FDA Post-Marketing Requirement
by each of the manufacturers of LABA containing asthma
treatments.
FDA Advisory Committees provide non-binding recommendations for
consideration by the FDA. Based on these opinions and the data
presented, the FDA will make its final decision on approval, which
is expected on 30 April 2015 (the Prescription Drug User Fee Act
goal date).
Breo, a fixed-dose combination of the inhaled corticosteroid FF
and the long-acting beta(2-) agonist VI, is administered with the
Ellipta dry powder inhaler device. The sNDA for Breo Ellipta in
asthma was submitted to the FDA in June 2014 for two once-daily
dose regimens, 100/25 mcg and 200/25 mcg.
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise,
said: "We recognise the Advisory Committee's thoroughness in
reviewing the data related to Breo Ellipta for asthma. We will
continue to work closely with the FDA while it considers the
Committee's recommendations and our aim is to answer any
outstanding questions to enable them to make a fully informed
decision."
Michael W. Aguiar, President and Chief Executive Officer of
Theravance, Inc., said: "We remain committed to the ongoing review
process and will be fully cooperating with the FDA to ensure it has
all it needs to consider the sNDA for Breo Ellipta in asthma. We
look forward to the final outcome expected in April.
About asthma
Asthma is a chronic lung disease that inflames and narrows the
airways.(1) Approximately 26 million people in the USA currently
have asthma.(2) Despite medical advances, more than half of
patients continue to experience poor control and significant
symptoms.(3)
The causes of asthma are not completely understood but likely
involve an interaction between a person's genetic make-up and the
environment. Key environmental risk factors for the development of
asthma are allergens, respiratory infections and airway
irritants.
*One panel member indicated that he intended to vote no, however
a vote cannot be changed once read into the official FDA
records.
About Breo Ellipta
Breo Ellipta (FF/VI 100/25 mcg) was licensed 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 Breo Ellipta.
Important Safety Information (ISI) for Breo Ellipta in the
US
The following ISI is based on the Highlights section of the US
Prescribing Information for Breo Ellipta 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 labelled 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 Ellipta 100 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
coadministration 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.
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. - 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(R) 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(R) 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 under
agreements entered into prior to the spin-off of Theravance
Biopharma, and since assigned to Theravance Respiratory Company,
LLC, 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 these agreements with GSK (other than
RELVAR(R) /BREO(R) ELLIPTA(R) , ANORO(R) ELLIPTA(R) and VI
monotherapy). For more information, please visit Theravance's web
site at www.thrxinc.com.
ANORO(R) , RELVAR(R) , BREO(R) and ELLIPTA(R) are trademarks of
the GlaxoSmithKline group of companies.
References:
1. Global Initiative for Asthma. Pocket Guide for asthma
management and prevention. Updated 2014.
2. American Lung Association, Epidemiology and Statitics Unit,
Research and Program Services Division,Trends in Asthma Morbidity
and Mortality, September 2012,
http://www.lung.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf(Last
accessed March 2015)
3. 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
Claire Brough +44 (0) 20 8047 (London)
5502
US Media enquiries: Sarah Alspach +1 202 715 1048 (Washington,
DC)
Mary Anne Rhyne +1 919 483 0492 (North Carolina)
Melinda Stubbee +1 919 483 2510 (North Carolina)
Jenni Ligday +1 202 715 1049 (Washington,
DC)
Karen Hagens +1 919 483 2863 (North Carolina)
Analyst/Investor Ziba Shamsi +44 (0) 20 8047 (London)
enquiries: 5543
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)
Theravance Inc. enquiries:
Investor Relations Eric d'Esparbes +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
2014.
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. Such forward-looking statements
involve substantial risks, uncertainties and assumptions. Examples
of such statements include statements relating to: the US FDA
following the joint advisory committee's recommendations, the
strategies, plans and objectives of the company, the timing, manner
and amount of anticipated potential capital returns to stockholders
(including without limitation, expectations of future cash
dividends or 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: the disruption of operations during the
transition period following the spin-off, including the diversion
of managements' and employees' attention, disruption of
relationships with collaborators and increased employee turnover,
lower than expected future royalty revenue from respiratory
products partnered with GSK, 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 headings "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" contained in Theravance's Annual Report on Form 10-K
for the year ended December 31, 2014 filed with the Securities and
Exchange Commission (SEC) on February 27, 2015. In addition to the
risks described above and in Theravance's other filings with the
SEC, other unknown or unpredictable factors also could affect
Theravance'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. Theravance assumes no
obligation to update its forward-looking statements on account of
new information, future events or otherwise, except as required by
law. (THRX-G)
(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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