LONDON and SAN FRANCISCO, April
30, 2015 /PRNewswire/ -- GlaxoSmithKline plc (LSE: GSK) and
Theravance, Inc. (NASDAQ: THRX) today announced that the US Food
and Drug Administration (FDA) has approved BREO®
ELLIPTA® (fluticasone furoate/vilanterol [FF/VI]) for
the once-daily treatment of asthma in patients aged 18 years and
older. Breo Ellipta is not indicated for the relief of acute
bronchospasm.
Breo is a fixed-dose combination of the inhaled corticosteroid
(ICS) fluticasone furoate (FF) and the long-acting
beta2-agonist (LABA) vilanterol (VI). Two strengths,
100/25mcg and 200/25mcg, have been approved in the US for use in
asthma, administered once-daily using the Ellipta dry powder
inhaler.
Darrell Baker, SVP & Head,
GSK Global Respiratory Franchise, said: "Asthma is a variable
condition and guidelines recommend a stepwise approach to treatment
with the aim of achieving asthma control. Breo Ellipta is our
second asthma treatment to be approved in the US in the past year,
and now provides physicians with a range of treatment options
delivered via the Ellipta inhaler to meet the needs of appropriate
adult patients with differing asthma severities."
Michael W. Aguiar, President and
Chief Executive Officer of Theravance, Inc., said: "We believe the
approval of Breo Ellipta as a once-daily ICS/LABA treatment for
adults with asthma is a significant catalyst for Theravance, as
asthma affects nearly 19 million adults in the US. We are pleased
by today's approval of Breo Ellipta and look forward to making this
important medicine available to the appropriate adult patients
among those living with the disease."
The FDA issued a complete response letter related to the
proposed use of Breo Ellipta in patients aged 12-17 stating that
the data submitted do not show adequate risk-benefit to support the
approval in these patients. The FDA stated that additional data
would be required to further demonstrate the safety and efficacy in
this population.
The efficacy and safety of Breo Ellipta was studied in a
clinical trial programme involving over 12,000 subjects in 23
studies of patients aged 12 and over.
Following submission of a supplemental new drug application
(sNDA) to the FDA, Breo Ellipta has been approved for the
once-daily treatment of asthma in patients aged 18 years and older.
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 hospitalisation in paediatric 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.
About asthma
Asthma is a chronic lung disease that
inflames and narrows the airways.1 Approximately 19
million adults in the US 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 are
likely to 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. For more information please see GSK's infographic
about adult asthma.
About Breo Ellipta
Breo Ellipta (FF/VI 100/25 mcg)
was licensed by the US FDA 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. An sNDA for Breo Ellipta in asthma was submitted to the
FDA in June 2014 and in April 2015 it was approved for the once-daily
treatment of asthma in patients aged 18 years and older. 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 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 Please consult the
full Prescribing Information for all the labelled safety
information for Breo Ellipta.
Long-acting beta2-adrenergic agonists (LABA), such
as vilanterol, increase the risk of asthma-related death. A
placebo-controlled trial with another LABA (salmeterol) showed an
increase in asthma-related deaths. This finding with salmeterol is
considered a class effect of all LABA. Currently available data are
inadequate to determine whether concurrent use of inhaled
corticosteroids (ICS) or other long-term asthma control drugs
mitigates the increased risk of asthma-related death from LABA.
Available data from controlled clinical trials suggest that LABA
increase the risk of asthma-related hospitalisation in paediatric
and adolescent patients. When treating patients with asthma,
only prescribe Breo Ellipta for patients not adequately controlled
on a long-term asthma control medication, such as an ICS, or whose
disease severity clearly warrants initiation of treatment with both
an ICS 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 ICS. Do not use Breo Ellipta for patients
whose asthma is adequately controlled on low- or medium-dose
ICS.
Breo Ellipta is contraindicated for primary treatment of status
asthmaticus or other acute episodes of COPD or asthma where
intensive measures are required and 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
asthma, or used for the relief of acute symptoms, i.e., as rescue
therapy for the treatment of acute episodes of bronchospasm. Acute
symptoms should be treated with an inhaled, short-acting
beta2-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 be advised to 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 hospitalisation. 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 longterm ketoconazole and
other known strong CYP3A4 inhibitors because increased systemic
corticosteroid and cardiovascular adverse effects may
occur.
Breo Ellipta can produce paradoxical bronchospasm which may be
life-threatening.
Hypersensitivity reactions such as anaphylaxis, angioedema,
rash, and urticaria may occur after administration of Breo
Ellipta.
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. Breo Ellipta should be used with caution
in patients with cardiovascular disorders.
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.
Orally inhaled corticosteroids may cause a reduction in growth
velocity when administered in children and adolescents.
For COPD, the most common adverse reactions (>3% and more
common than in placebo) reported in two 6-month clinical trials
with Breo Ellipta 100/25 (and placebo) were nasopharyngitis, 9%
(8%); upper respiratory tract infection, 7% (3%); headache, 7%
(5%); and oral candidiasis, 5% (2%). In addition to the
reactions reported in the 6-month studies, adverse reactions
occurring in >3% of the subjects treated with Breo Ellipta
100/25 in two 1-year studies included back pain, pneumonia,
bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia,
influenza, pharyngitis, and pyrexia.
For asthma, the most common adverse reactions in a 12-week trial
(incidence >2% and more common than placebo) reported with Breo
Ellipta 100/25 (and placebo) were nasopharyngitis 10% (7%),
headache 5% (4%), oropharyngeal pain 2% (1%), oral candidiasis 2%
(0%), and dysphonia 2% (0%). In a separate 12-week trial the most
common adverse reactions (>2% incidence) reported with Breo
Ellipta 100/25 or 200/25 were headache, nasopharyngitis, influenza,
upper respiratory tract infection, oropharyngeal pain, sinusitis,
bronchitis, and cough. In addition to adverse reactions reported in
the 12 week studies, adverse reactions (>2% incidence) reported
with Breo Ellipta 200/25 in a 24-week trial included viral
respiratory tract infection, pharyngitis, pyrexia, and arthralgia,
and with Breo Ellipta 100/25 or 200/25 in a 12-month trial included
pyrexia, back pain, extrasystoles, upper abdominal pain,
respiratory tract infection, allergic rhinitis, pharyngitis,
rhinitis, arthralgia, supraventricular extrasystoles, ventricular
extrasystoles, acute sinusitis, and pneumonia.
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®/BREO®
ELLIPTA® and ANORO®
ELLIPTA®, with the intention of providing capital
returns to stockholders. Under the Long-Acting
Beta2 Agonist (LABA) Collaboration Agreement with
GSK, Theravance is eligible to receive the associated royalty
revenues from RELVAR®/BREO®
ELLIPTA® (fluticasone furoate/vilanterol,
"FF/VI"), ANORO® ELLIPTA®
(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-Beta2 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®/BREO®
ELLIPTA®, ANORO®
ELLIPTA® and VI monotherapy). For more
information, please visit Theravance's web site at
www.thrxinc.com.
ANORO®, RELVAR®, BREO® and
ELLIPTA® are trade marks of the GlaxoSmithKline group of
companies.
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
commercialization of BREO ELLIPTA in the US, 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)
References:
- Global Initiative for Asthma. Pocket Guide for Asthma
Management and Prevention. Updated 2015.
- Blackwell et al. NHIS, 2012. Vital Health Stat
2014;10(260):19.
- Demoly et al. Eur Respir Rev. 2012 Mar
1;21(123):66-74. doi: 10.1183/09059180.00008111.
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