FDA Panel OKs Wider Use Of Advair

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Glaxo execs may breathe easier now.

The FDA advisory committee voted unanimously to recommend that the strongest does of the ashthma inhaler, which is the world’s second best-selling drug, be used to reduce symptoms of a common lung disease linked to smoking. Advair would be used to reduce flare-ups of breathing difficulty in patients with chronic obstructive pulmonary disease, or smoker’s cough.

However, the panel voted 9 to 2 that there isn’t convincing evidence Advair increases survival.

Expanding the approved uses for patients with the disease would help Glaxo counter slowing growth of Advair sales, which totaled $6 billion worldwide last year. Wider use of stronger, more expensive inhalers could boost the company’s profit by as much as 8 percent, an analyst said.

“Based on the literature that’s out there, there will be a number of patients put on this drug,” said panel member Polly Parsons, director of the pulmonary and critical care unit at Fletcher Allen Health Care in Burlington, Vermont, at the FDA meeting today in Gaithersburg, Maryland.

The FDA usually follows the recommendations of its advisers, though it isn’t required to do so. The agency is expected to make a final decision on expanded use of Advair by August 11.

Advair is prescribed to reduce inflammation and narrowing of airways when taken twice daily. The highest dose costs about $225.24, or 37 percent more than the middle-dose product, Advair 250/50, according to analysts.

“Expansion of the eligible patient population by 20 percent to 30 percent could add up to 3 percent to 5 percent to GSK’s earnings,” Bear Stearns analyst Alexandra Hauber wrote in an April 26 research report. An approval of a higher dosage for smoker’s cough may add another 2 percent to 3 percent to earnings, Hauber said.

Source: Bloomberg News.[tags]Advair, GlaxoSmithKline[/tags]

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