GSK SUBMITS SNDA FOR ADVAIR IN COPD

GlaxoSmithKline (GSK) announced that it has submitted a supplemental new drug application (sNDA) to the FDA to expand labeling for Advair Diskus (fluticasone propionate/salmeterol inhalation powder) in the U.S. based on results from TORCH, a three-year study that showed a reduction in the risk of death and the rate of chronic obstructive pulmonary disease (COPD) exacerbations, and other supporting studies.

More than 6,000 patients with COPD were enrolled in the TORCH study, which was conducted at more than 400 centers in 42 countries. Patients were enrolled in one of four treatment groups: Advair (500/50 micrograms), Serevent (salmeterol, 50 micrograms), Flovent (fluticasone propionate, 500 micrograms) or placebo. Use of other COPD medications (except inhaled corticosteroids and long-acting bronchodilators) was allowed and was similar in the four treatment arms.

Results of the TORCH study showed a 17.5 percent reduction in risk of death from any cause over three years for patients receiving Advair as compared with patients on placebo. Advair also reduced the rate of COPD exacerbations by 25 percent compared with placebo. Quality of life, as measured by the St George's Respiratory Questionnaire, was improved by Advair when compared to placebo 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.

Advair 250/50 micrograms is currently indicated for the maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis. The sNDA seeks marketing approval for Advair 500/50 micrograms and expanded labeling based on data from TORCH and other supporting studies.