RESEARCH TRIANGLE PARK, N.C., May 1 /PRNewswire-FirstCall/ -- Late
yesterday the U.S. Food and Drug Administration approved Advair Diskus(R)
250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation
powder) for the reduction of exacerbations in patients with chronic
obstructive pulmonary disease (COPD) who have a history of exacerbations.
With this approval, Advair becomes the only treatment FDA has approved to
reduce COPD exacerbations. Treatment guidelines for COPD state that the
reduction of exacerbations is a key goal in managing the disease.
COPD is a progressive, life-threatening lung disease that includes chronic
bronchitis, emphysema or both. Exacerbations are flare-ups or episodes of
worsening COPD symptoms that often require additional treatment, such as
antibiotics, oral corticosteroids and in some cases hospitalization. Symptoms
may include coughing, shortness of breath, or coughing up excess mucus beyond
normal day-to-day variations. Seventy-seven (77) percent of patients with COPD
report experiencing at least one exacerbation within the past year.
"This is good news for my patients with COPD because Advair now brings an
additional benefit in managing their disease," said Gary Ferguson, MD,
Pulmonary Research Institute of Southeast Michigan. "My goal as a physician
is to help reduce the number of exacerbations my patients experience and
Advair 250/50 will be a critical treatment in helping meet that goal."
The FDA also expanded the use of Advair Diskus 250/50 to a broader patient
population which includes not only patients with COPD associated with chronic
bronchitis, but also emphysema or both conditions. Advair 250/50 is the only
approved strength for COPD in the U.S., because an efficacy advantage of the
higher strength over Advair 250/50 has not been demonstrated.
Advair contains two medicines, an inhaled corticosteroid (fluticasone
propionate) and a long-acting beta-agonist (salmeterol), that work together to
improve lung function and reduce exacerbations, two primary goals in the
management of COPD.
Clinical Data
Two identical one-year studies were conducted to evaluate the effect on
COPD exacerbations with Advair Diskus 250/50 compared to 50 mcg of salmeterol
alone, each given twice daily. A total of 1,579 patients with an established
history of COPD exacerbations were enrolled. Patients treated with Advair
Diskus 250/50 had a 30% reduction in the rate of annual exacerbations compared
to salmeterol (p<0.001). Additionally, patients treated with Advair had a
significantly lower annual rate of exacerbations requiring treatment with oral
corticosteroids compared with patients treated with salmeterol (39.7%
reduction [95% CI: 22.8, 52.9], p <0.001). Secondary endpoints including
pulmonary function and symptom scores improved more in patients treated with
Advair 250/50 than with salmeterol 50 mcg in both studies.
The studies conducted to support the new indication were one year in
duration, thus lengthening the duration of established efficacy and safety in
patients with COPD.
Background on COPD
An estimated 24 million Americans suffer from COPD, which is the fourth
leading cause of death in the United States. COPD is a progressive,
life-threatening lung disease that includes chronic bronchitis and emphysema.
It is characterized by airflow obstruction, a limitation in lung function that
makes it difficult to breathe. Most patients have components of both chronic
bronchitis and emphysema. Symptoms of COPD include chronic cough, chest
tightness, shortness of breath, an increased effort to breathe and increased
mucus production. Typically, patients with COPD develop shortness of breath
during exertion, which continues and gradually worsens. Most patients also
develop a productive, chronic cough. Over time, many patients suffer from
shortness of breath so severe that it interferes with their most basic daily
activities including sleeping, talking, and even dressing. The gradual loss of
lung function, coupled with other symptoms and exacerbations, often lead to
hospitalization and can be disabling and life-threatening.
About Advair in COPD
Advair Diskus 250/50 was originally approved in 2003 for the maintenance
treatment of airflow obstruction in patients with COPD associated with chronic
bronchitis. With the new approval, Advair Diskus 250/50 is indicated for the
maintenance treatment of airflow obstruction in patients with COPD, including
chronic bronchitis and/or emphysema. Advair Diskus 250/50 is also indicated to
reduce exacerbations in patients with a history of exacerbations. Advair
Diskus 250/50 is the only approved strength for COPD because an efficacy
advantage of the higher strength Advair Diskus 500/50 over Advair Diskus
250/50 has not been demonstrated.
Patients should only take one inhalation of Advair twice a day. People
with COPD taking Advair may have a higher chance of pneumonia. Patients should
call their doctor if they notice any of the following symptoms: change in
amount or color of sputum, fever, chills, increased cough, or increased
breathing problems. Advair may increase the risk of osteoporosis and some eye
problems (cataracts or glaucoma). Patients should have regular eye exams.
Thrush in the mouth and throat may occur. Patients should tell their doctor if
they have a heart condition or high blood pressure before taking Advair. Do
not use Advair with long-acting beta2-agonists for any reason. Advair does not
replace fast-acting inhalers for sudden symptoms.
For more information about Advair please visit http://www.gsk.com.
About GlaxoSmithKline (NYSE: GSK)
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies. 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.
SOURCE GlaxoSmithKline
