Pharmaceutical Business review

GSK applies for expanded FDA approval of Advair

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.

Results of the study showed a 17.5% 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% compared with placebo. Quality of life was also improved by Advair.

However the trial did miss its primary endpoint of showing a statistically significant reduction in risk of death.

In the study, Advair was associated with increased reporting of pneumonia when compared with placebo. Other adverse events generally appear consistent with those seen in previous studies of Advair in patients with COPD.

Advair is currently indicated for the maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis and is GlaxoSmithKline's biggest selling drug.