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: Glaxo wins FDA approval for wider Advair use
From: Reuters
Published April 30, 2008 05:53 PM

Glaxo wins FDA approval for wider Advair use

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.

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

There is no treatment for COPD, which is closely linked to smoking and is the fourth leading cause of death in the United States. Drugs can, however, treat the disease's symptoms.

Both Advair and Symbicort, inhaled treatments that combine a corticosteroid and a long-acting beta-agonist, are already approved to treat asthma.

(Reporting by Susan Heavey; Editing by Andre Grenon and Carol Bishopric)

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