FDA Approves Advair 250/50 for Reduction of Exacerbations in Patients With COPD

Advair 250/50 Now the Only Treatment Approved to Both Reduce Exacerbations and Improve Lung Function

RESEARCH TRIANGLE PARK, N.C., April 30, 2008 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration today approved Advair Diskus 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 www.gsk.com.

About GlaxoSmithKline

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 www.gsk.com.

CONTACT: US Media Inquiries: Patty Johnson, or Lisa Behrens, or Mary AnneRhyne, +1-919-483-2839, or US Analyst/Investor Inquiries: Frank Murdolo,+1-215-751-7002, or Tom Curry, +1-215-751-5419, all of GlaxoSmithKline

Web site: http://www.gsk.com/

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Posted: May 2008

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