FDAnews Drug Daily Bulletin


April 5, 2006

GlaxoSmithKline's (GSK) asthma drug Advair improves survival rates in patients with chronic obstructive pulmonary disease (COPD), according to preliminary study results.

The 6,100-patient clinical trial, known as TORCH, showed a 17-percent relative reduction in mortality over three years for COPD patients receiving Advair (salmeterol/fluticasone propionate) 50/500 micrograms as compared to patients on placebo, GSK said recently.

Advair 50/500 is not licensed in the U.S. for patients with COPD.

In addition, Advair reduced the rate of COPD exacerbations by 25 percent compared to placebo, and also resulted in an improved quality of life when compared to placebo as measured by the St. George's Respiratory Questionnaire index.

"GSK believes these data are clinically important and that they will have a positive impact on the future management of COPD," the company said. "GSK will be working with regulatory authorities to incorporate these study findings into our prescribing information for Advair (50/500 micrograms)," it added.