Healthcare Industry News:  GSK 

Biopharmaceuticals FDA

 News Release - October 11, 2006

GSK Submits Supplemental Drug Application for Advair in COPD

Study results showed reduction in risk of death and rate of exacerbations from life-threatening lung disease

RESEARCH TRIANGLE PARK, N.C., Oct. 11 (HSMN NewsFeed) -- GlaxoSmithKline announced today that it has submitted a supplemental new drug application to the FDA to expand labeling for Advair DiskusŪ (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


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), SereventŪ (salmeterol, 50 mcg), FloventŪ (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 .

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

Source: GlaxoSmithKline

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