Study results showed reduction in risk of death and rate of exacerbations
from life-threatening lung disease
RESEARCH TRIANGLE PARK, N.C., Oct. 11 /PRNewswire/ -- GlaxoSmithKline
announced today that it has submitted a supplemental new drug application
to the FDA to expand labeling for Advair Diskus(R) (fluticasone propionate
and salmeterol inhalation powder) based on results from TORCH, a three year
study that showed a reduction in the risk of death and the rate of COPD
exacerbations, and other supporting studies.
COPD, or chronic obstructive pulmonary disease, is a complex lung
disease that results in a progressive decline in lung function that is
ultimately debilitating and life-threatening. It is the 4th leading cause
of death in the U.S.
Results of the TORCH study (TOwards a Revolution in COPD Health) showed
a 17.5% reduction in risk of death from any cause over three years for
patients receiving Advair 500/50 as compared with patients on placebo
(p=0.052). Advair also reduced the rate of COPD exacerbations by 25%
compared with placebo (p<0.001). Quality of life, as measured by the St
George's Respiratory Questionnaire (SGRQ), was improved by Advair 500/50
when compared to placebo (p<0.001) although it did not meet the predefined
magnitude of difference. In the study, Advair was associated with increased
reporting of pneumonia when compared with placebo (p<0.001). Other adverse
events (e.g. candidiasis, dysphonia, contusion) generally appear consistent
with those seen in previous studies of Advair in patients with COPD.
Advair 250/50 is currently indicated for the maintenance treatment of
airflow obstruction in patients with COPD associated with chronic
bronchitis. The supplemental drug application seeks marketing approval for
Advair 500/50 and expanded labeling based on data from TORCH and other
supporting studies. GSK submits supplemental drug application for Advair in
COPD - page 2
About TORCH
More than 6000 patients with COPD were enrolled in the TORCH study
which was conducted at more than 400 centers in 42 countries. The primary
endpoint for the three year trial was a difference in death from any cause
comparing Advair 500/50 and placebo. Secondary endpoints were COPD
exacerbations (sudden worsening of symptoms) and changes to quality of
life. Patients were enrolled in one of four treatment groups: Advair
(500/50 mcg), Serevent(R) (salmeterol, 50 mcg), Flovent(R) (fluticasone
propionate, 500 mcg) or placebo. Use of other COPD medications (except
inhaled corticosteroids and long-acting bronchodilators) was allowed and
was similar in the four treatment arms.
About COPD
It's estimated that as many as 20 million Americans have COPD. COPD,
which includes chronic bronchitis and emphysema, has several components
including inflammation, bronchoconstriction and structural changes in the
airways that restrict airflow in the lungs. Patients typically develop
breathlessness and a chronic cough that worsen over time and the
progressive decline in lung function eventually begins to disable patients
and contributes to an overall decline in quality of life. The loss of lung
function, coupled with other symptoms and exacerbations can lead to
life-threatening events and death.
Improving survival remains a major unmet need for patients with COPD.
By 2020, it's predicted that COPD will be the third leading cause of death
and fifth leading cause of disability worldwide.
About Advair in COPD
Advair 250/50 is currently indicated for the maintenance treatment of
airflow obstruction in patients with COPD associated with chronic
bronchitis. Advair does not replace fast-acting inhalers to treat sudden
symptoms. Lower respiratory tract infections, including pneumonia, have
been reported following the inhaled administration of corticosteroids,
including fluticasone propionate and Advair Diskus. Patients with COPD
often have multiple risk factors for reduced bone mineral density. Advair
Diskus may increase this risk; therefore, bone mineral density assessment
is recommended prior to starting Advair Diskus and periodically thereafter.
Long-term use of inhaled corticosteroids, including Advair Diskus, may
increase the risk for cataracts or glaucoma. Regular eye exams should be
considered.
For more information about Advair please visit http://www.gsk.com .
About GlaxoSmithKline
Advair was developed and is marketed by GlaxoSmithKline, a research
based pharmaceutical company and a world leader in respiratory care.
GlaxoSmithKline is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For company
information visit http://www.gsk.com
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SOURCE GlaxoSmithKline
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US Media inquiries, Lisa Behrens,
+1-919-483-2839, or Mary Anne Rhyne, +1-919-483-2319, or UK Media
inquiries, Philip Thomson, Gwenan Evans, or Alice Hunt, (020)
8047 5502, or US Analyst-Investor inquiries, Frank Murdolo,
+1-215-751-7002, or Tom Curry, +1-215-751-5419, Jen Hill,
+1-215-751-7199, or European Analyst-Investor inquiries, Anita
Kidgell, (020) 8047 5542, or David Mawdsley, (020) 8047 5564
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