Glaxo wins U.S. FDA approval for wider Advair use

By Susan Heavey

WASHINGTON (Reuters) - U.S. health regulators have said GlaxoSmithKline Plc's (GSK.L)(GSK.N) Advair is safe and effective to more widely treat patients with chronic obstructive pulmonary disease (COPD), the drugmaker said on Wednesday.

Glaxo's approval comes the same day as rival AstraZeneca Plc (AZN.L) (AZN.N) said it also was seeking U.S. Food and Drug Administration approval to sell its drug Symbicort for COPD.

COPD, an often-fatal lung condition with no cure, is a major market with more than 12 million Americans suffering from the disease, and another 12 million who are likely not diagnosed, according to the National Institutes of Health.

The FDA's approval allows Glaxo to promote its product to COPD patients who experience flare-ups of the disease, which includes emphysema and chronic bronchitis.

In a statement, Glaxo said the FDA also approved the use of Advair to include "not only patients with COPD associated with chronic bronchitis, but also emphysema or both conditions."

Advair already is approved to prevent wheezing and to control other COPD symptoms.

Earlier on Wednesday, AstraZeneca said it had submitted an application to the FDA seeking approval to market Symbicort for COPD based on two clinical trials, setting up competition

for the lucrative market.