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October 11, 2006

GSK Submits SDA for Advair in COPD

  • GlaxoSmithKline submitted a supplemental new drug application to expand labeling for Advair Diskus® (fluticasone propionate and salmeterol inhalation powder), based on studies that showed reduced death risk and rate of chronic obstructive pulmonary disease (COPD) exacerbations.

    Results from GSK’s three-year 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). In addition, it reduced the rate of COPD exacerbations by 25% compared with placebo (p<0.001). Advair also improved quality of life when compared to placebo (p<0.001), although it did not meet the predefined magnitude of difference.

    The company observed, however, that Advair was associated with increased reporting of pneumonia 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.

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