RESEARCH TRIANGLE PARK, N.C.,
Jan. 26, 2015 /PRNewswire/
-- GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the
simultaneous availability of two of its recently approved products
for the treatment of asthma and COPD to retail pharmacies in the
US. Over the past 15 months, GSK has launched four inhaled
respiratory therapies in the US, all delivered in its
Ellipta® inhaler.
Arnuity™ Ellipta (fluticasone furoate inhalation
powder) is a once-daily inhaled corticosteroid (ICS) medicine for
the maintenance treatment of asthma. It is the first product in the
Ellipta inhaler for the treatment of asthma to be introduced in the
US.
Arnuity Ellipta is indicated for once-daily maintenance
treatment of asthma as prophylactic therapy in patients aged 12
years and older. Arnuity Ellipta is not indicated for the
relief of acute bronchospasm. It acts to reduce inflammation
associated with asthma and helps to prevent and control the
symptoms of asthma.
Arnuity Ellipta is available in two approved doses, 100mcg and
200mcg.
GSK also announced today that
Incruse® Ellipta®
(umeclidinium bromide), an anticholinergic indicated for the
long-term, once-daily maintenance treatment of airflow obstruction
in patients with chronic obstructive pulmonary disease (COPD),
including chronic bronchitis and/or emphysema, is now available to
retail pharmacies in the US. Incruse is GSK's first
anticholinergic monotherapy, a type of bronchodilator that can
relax airway smooth muscles and improve airflow in and out of the
lungs. Incruse Ellipta is available as 62.5mcg of umeclidinium dry
inhalation powder, administered once-daily using the Ellipta
inhaler.
"We're excited to share this news with patients. Forty years
after the launch of our first respiratory therapy, we remain
committed to innovation and helping a wide range of appropriate
patients. These are the third and fourth respiratory products we've
introduced since October 2013 in our
patented Ellipta inhaler," said Jorge
Bartolome, Senior Vice President of the GSK Respiratory
Business Unit in the US. "The Ellipta allows for a common inhaler
platform across our inhaled therapies approved since
2013."
GSK has made available a new "FREE to you for 12 months" coupon
for Incruse Ellipta and Arnuity Ellipta. The savings offer coupon
will pay the entire out-of-pocket (OOP) cost for eligible
commercial and cash patients for up to twelve months.
(Eligibility and other limitations apply.) This new "FREE to you
for 12 months" savings offer is also available with some of our
other GSK products. For more information, visit
www.gskforyou.com.
Full U.S. Prescribing Information, including Patient Information
Leaflets, is available at us.gsk.com. For images of Arnuity
Ellipta and Incruse Ellipta, please see our press kit.
About asthma
Asthma is a chronic lung disease that inflames and narrows the
airways.1 Approximately 26 million people 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 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 COPD
COPD is a common, preventable and progressive disease, which
includes a range of conditions that limit airflow to the
lung. COPD is characterized by obstruction to airflow that
interferes with normal breathing. The National Heart, Lung, and
Blood Institute (NHLBI) estimates that nearly 27 million people in
the US alone are affected by COPD.4
According to the NHLBI, long-term exposure to lung irritants
that damage the lungs and the airways are usually the cause of
COPD. In the United States, the
most common irritant that causes COPD is cigarette smoke. Breathing
in secondhand smoke, air pollution, chemical fumes or dust from the
environment or workplace also can contribute to COPD. Most people
who have COPD are at least 40 years old when symptoms begin.
Important Safety Information for Arnuity
Ellipta
The following Important Safety Information is based on the
Highlights section of the Prescribing Information for Arnuity
Ellipta. Please consult the full Prescribing Information for all
the labeled safety information for Arnuity Ellipta.
Arnuity Ellipta is contraindicated for primary treatment of
status asthmaticus or acute episodes of asthma requiring intensive
measures and in patients with severe hypersensitivity to milk
proteins or any ingredients of Arnuity Ellipta.
Candida albicans infection of the mouth and throat may
occur in patients treated with Arnuity Ellipta.
Do not use Arnuity Ellipta for the relief of acute symptoms.
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.
Risk of impaired adrenal function when transferring from
systemic corticosteroids. Wean patients slowly from systemic
corticosteroids if transferring to Arnuity Ellipta.
Hypercorticism and adrenal suppression may occur with very high
dosages or at the regular dosage in susceptible individuals.
Discontinue Arnuity Ellipta and institute alternative therapy if
paradoxical bronchospasm occurs.
Monitor patients with major risk factors for decreased bone
mineral content.
Monitor growth of adolescent patients.
Close monitoring for glaucoma and cataracts is warranted.
The most common adverse reactions (reported in greater than or
equal to 5% of subjects) with Arnuity Ellipta were upper
respiratory tract infection, nasopharyngitis, headache, and
bronchitis.
Use Arnuity Ellipta with caution in patients taking strong
cytochrome P450 3A4 inhibitors (e.g., ketoconazole) because this
may cause systemic corticosteroid effects.
Fluticasone furoate exposure may increase in patients with
moderate or severe hepatic impairment. Monitor for systemic
corticosteroid effects.
Important Safety Information for Incruse Ellipta
The following Important Safety Information is based on the
Highlights section of the Prescribing Information for Incruse
Ellipta. Please consult the full Prescribing Information for all
the labeled safety information for Incruse Ellipta.
Incruse Ellipta is contraindicated in patients with severe
hypersensitivity to milk proteins or who have hypersensitivity to
umeclidinium, or any of the other ingredients.
Incruse 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, which should be treated with an inhaled, short-acting
beta2-agonist.
Incruse Ellipta can produce paradoxical bronchospasm, which may
be life-threatening.
Incruse Ellipta should be used with caution in patients with
narrow-angle glaucoma. Instruct patients to contact a physician
immediately should any signs or symptoms of narrow-angle glaucoma
occur.
Incruse Ellipta should be used with caution in patients with
urinary retention, especially in patients with prostatic
hyperplasia or bladder neck obstruction. Instruct patients to
contact a physician immediately should any signs or symptoms of
urinary retention occur.
The most common adverse reactions (incidence ≥2% and more common
than placebo) with Incruse Ellipta (and placebo) were
nasopharyngitis, 8% (7%); upper respiratory tract infection, 5%
(4%); cough, 3% (2%); and arthralgia, 2% (1%). Other adverse
reactions with Incruse Ellipta observed with an incidence less than
1% but more common than placebo included atrial fibrillation.
Avoid co-administration of Incruse Ellipta with other
anticholinergic-containing drugs as this may lead to an increase in
anticholinergic adverse effects such as worsening of narrow-angle
glaucoma, and worsening of urinary retention.
Arnuity™ is a trademark and Incruse®
and Ellipta® are registered trademarks of the GSK group
of companies.
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.
References
- Global Initiative for Asthma. Pocket Guide for asthma
management and prevention. Updated 2014.
- American Lung Association, Epidemiology and Statistics Unit,
Research and Program Services Division,Trends in Asthma
Morbidity and Mortality, September
2012,
www.lungusa.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf
- Demoly et al. Eur Respir Rev. 2012 Mar 1;21(123):66-74. doi:
10.1183/09059180.00008111.
- National Heart, Lung, and Blood Institute. 2012 Chart Book on
Cardiovascular, Lung, and Blood Diseases. February 2012,
https://www.nhlbi.nih.gov/files/docs/research/2012_ChartBook_508.pdf
GSK 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.
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SOURCE GlaxoSmithKline plc