Last updated at 10:32 PM on 14th July 2010
Comments (0) Add to My Stories GlaxoSmithKline received a major boost in its fight with US regulators as a majority of American health advisers said its blockbuster diabetes drug Avandia did not raise concerns about the risk of death and should stay on the market in some form.
Twenty members of the 33-member expert panel gave the drug their backing. Only 12 members voted to recommend that the authorities withdraw the pill.
By a closer 12-to-7 margin, the panel found no death concern with Avandia compared with Takeda Pharmaceutical's Actos, a drug in the same class as Avandia. Fourteen could not decide.
Major Boost: US health advisers said that Glaxo's Avandia should stay on the market in some form
However, the scientific experts found Avandia did raise a heart attack concern compared with other classes of diabetes drugs, and when compared Actos.
Avandia's US sales were just 1.5 per cent of Glaxo's 2009 revenues, but investors fear the company could face more lawsuits if the drug is pulled from the market.
The Food and Drug Administration convened the panel of outside experts to help the agency settle a three-year safety dispute over Avandia.
In 2007, an advisory panel voted 20-to-3 that Avandia may increase the chances of a heart attack for some patients. But they voted 22-to-1 to recommend that the drug stay on the market.
The FDA will make its final decision in the coming months, but usually follows the advice of its panels.
The debate on Avandia's safety has raged since warnings were placed on the drug in 2007 saying some research linked the drug to a higher heart attack risk but the data is 'inconclusive'.
Shares in Glaxo closed up 5p at 1181.5p.
Read more: http://www.dailymail.co.uk/money/article-1294776/Experts-ease-fears-Glaxo-drug.html?ito=feeds-newsxml#ixzz0thQBUQvh
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