Higher Dose Advair Questioned By FDA Panel

A U.S. panel says there is not enough evidence to show that higher doses of Advair help chronic obstructive pulmonary disease patients live longer.

GlaxoSmithKline is asking the Food and Drug Administration to approve higher dose of Advair to treat patients with chronic obstructive pulmonary disease, or COPD, The Wall Street Journal said Wednesday.

One study submitted to the FDA panel showed a 2.6 percent improvement in survival over three years among patients receiving Advair. The panel said the survival benefit was only 1.6 percent when only U.S. patients were taken into consideration.

The panel said it also was concerned about a higher rate of infections such as pneumonia among those receiving Advair.

The panel, however, said the study did show that Advair caused a meaningful decrease in COPD exacerbations, and that the drug had an advantage over salmeterol alone, the newspaper said.

Advair is a combination of fluticasone and salmeterol.