From: Reuters
Published March 5, 2008 12:35 PM

FDA requests more safety data on asthma drugs

WASHINGTON (Reuters) - U.S. health officials said on Wednesday they had requested more information from GlaxoSmithKline Plc <GSK.L> and other makers of asthma drugs to further analyze the safety of the medicines.

The drugs, known as long-acting beta agonists, include Glaxo's Advair and Serevent, Novartis AG's <NOVN.VX> Foradil, and AstraZeneca Plc's <AZN.L> <AZN.N> Symbicort. They are used to treat asthma and other respiratory conditions.

The Food and Drug Administration said it had asked the manufacturers in January to provide information from controlled clinical studies of the medicines "in order to further evaluate the safety" when treating asthma.

Other manufacturers include Mylan Inc <MYL.N>, which sells Perforomist, and Sepracor Inc <SEPR.O>, maker of Brovana.


The companies said it would take several months to submit the information, the FDA said in a notice on the agency Web site.

The agency plans to ask a panel of outside advisers to review the drugs' risks and benefits in adults and children in the fall or winter 2008, the notice said.

In November 2007, an FDA advisory panel urged stronger safety warnings on Glaxo's Serevent amid reports of deaths in children who were treated with the drug. Serevent is one ingredient in Glaxo's blockbuster asthma treatment Advair.

Glaxo shares ended down 2.6 percent at 10.65 pounds in London. Advair is Glaxo's biggest selling drug with 2007 global sales of 3.5 billion pounds ($6.9 billion), of which 1.9 billion pounds was generated in the United States.

The long-acting beta agonists "have been reviewed several times already, but with current political pressure and ongoing safety reviews, I'm not that surprised it has come up again," said Ben Yeoh, pharmaceuticals analyst at Dresdner Kleinwort.

($1=.5052 Pound)

(Reporting by Lisa Richwine and Ben Hirschler, editing by Maureen Bavdek)

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