The U.S. Food and Drug Administration is questioning whether or not the rate of survival in patients taking GlaxoSmithKline PLC’s Advair® is strong enough to broaden the product’s indications by approving a new use.
The drug manufacturer is requesting that the FDA approve the highest dose of Advair®—500/50 micrograms—for treatment of patients suffering from chronic obstructive pulmonary disease (COPD) to increase survival benefits and reduce exacerbations.
Currently, a lower dose of 250/50 micrograms is approved for the treatment of COPD, but the label on the drug doesn’t state the survival benefits.
An agency advisory panel will review the data and recommend a course of action. The FDA isn’t required to follow the panel’s advice, but usually do.
Advair® “Black-Box” Warning
Advair® is also commonly prescribed to treat patients with severe asthma. However, in 2005, the drug was required to carry a black-box warning—the strongest FDA warning—indicating the serious side effects associated with its use.
According to a number of reports, Advair® may cause severe, potentially life-threatening asthma attacks in some users.
Clinical Trials
GlaxoSmithKline submitted the results of several clinical studies involving 6,112 patients to the FDA in support of Advair®’s new indication.
The study found a 2.6 percent improvement in the rate of survival over a three-year period in patients treated with Advair® compared to a placebo. But the survival benefits in U.S. patients was only 1.6 percent.
While the study indicated that Advair® “consistently” reduced moderate to severe COPD exacerbations, the drug raised the risk of other serious infections such as pneumonia.
“This alone suggests that there is still much to learn about…COPD and that treatment with (Advair®) should be reserved to patients most likely to respond,” the FDA said.
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