Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.UK-based GlaxoSmithKline has submitted a new drug application to the FDA to expand the labeling for Advair based on results from a study that showed a reduction in the risk of death from chronic obstructive pulmonary disease.
Subscribe to our email newsletter
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.