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Avandia wins FDA reprieve

The FDA's advisory votes 22 to 1 in favour to keep GSK's troubled diabetes drug Avandia on the US market

The FDA's advisory committee has voted 22 to 1 in favour to keep UK-headquartered GlaxoSmithKline's (GSK) troubled diabetes drug Avandia (roseglitazone) on the US market.

On 30 July, GSK presented new data to Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

They voted that the data suggests some ischemic risk with Avandia, a treatment for type 2 diabetes. The committee declined to comment on comparative risk of Avandia with other oral anti-diabetic medicines, but nevertheless voted to keep the medicine available to patients in the US. The FDA will review the panel's recommendation before making a final decision.

"This was the first opportunity for these scientific experts to review the full data behind Avandia. The committee recognized the debilitating nature of this disease and the importance of multiple treatment options," said Dr Ronald Krall, GSKís CMO.

Concerns over Avandia were first raised in May 2007, when the New England Journal of Medicine (NEJM) published research claiming the treatment could increase the risk of heart attacks.

In the EU, both the European Medicines Agency (EMEA) and the UK's Medicines Healthcare Regulatory Agency (MHRA) are re-evaluating the drug's benefits in light of possible links with heart failure.

GSK has maintained its forecast for FY07 earnings per share growth of eight to 10 per cent following the panel's decision.

31st July 2007

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