Glaxo's Diabetes Pill Avandia Remains on the Market

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Glaxo's Diabetes Pill Avandia Remains on the Market

A panel of advisers to the FDA voted that Glaxo’s diabetes pill Avandia should remain on the market. They said there was not enough evidence to justifying stopping sales.

The panel did however agree that the drug does cause an increase in the risk of heart attacks. Some of the panel recommended that the FDA should take steps to limit use of the drug.

• Avandia has annual sales of $3 billion
• 7 million people have used it
• It is Glaxo's second-best selling drug
• and represents around 6% of the group's total turnover.

The panel voted 20-3 that Avandia increases the risks of heart attacks and voted 22-1 that it should nevertheless remain on the market. Most of the panel recommended the inclusion of a strong warning on heart attacks.

Some panelists also recommended the use of a black box warning, the most severe warning used by the FDA. Many said Avandia should not be approved for use with insulin, as patients who got both drugs were at the highest risk of a heart attack.

Chris Viehbacher, Glaxo's president of US pharmaceuticals, said that "there is no difference" in heart attack risk between Avandia and other diabetes pills.

In a separate devlopment Glaxo’s Australian partner on flu drug Relenza has increased its claim for damages to $600 million, accusing Glaxo of failing to promote the product properly.

Biota Holdings Ltd. started its litigation in May 2004 but had previously been seeking up to A$430 million.

Glaxo has rejected Biota's claim arguing that it has met its obligations. The case will no tbe tried until April 1, 2008 in Melbourne

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Glaxo shares have fallen 16% since May when Avandia was linked to a 43% increased risk of heart attacks.

The share price was up over 5% in early trading, it is now up 3.5% with the FTSE up 123 points.


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