Panel votes to keep GSK's diabetes drug on market

Avandia, the blockbuster diabetes treatment owned by GlaxoSmithKline, was yesterday given the green light to stay on the market despite data suggesting an increased incidence of heart attacks among those taking the drug.

Two committees at the US Food & Drug Administration, the Washington-based pharmaceuticals regulator, voted 22 to 1 in favour of recommending that American doctors be allowed to continue prescribing the drug to diabetes sufferers. It is not yet known who voted against.

The recommendation - which is usually followed by the FDA - will come as a relief to GlaxoSmithKline which last year made Pounds 1.4 billion in sales from the drug globally, of which Pounds1 billion was made in the USA. The treatment, which makes the body more sensitive to insulin, is the pharmaceutical company's second biggest selling drug after Advair, its asthma treatment.

Members of the panels, which included world experts on diabetes and scientists who specialise in analysing clinical trial data, were asked to vote on whether they believed that available data supported a conclusion that Avandia increased the risk of cardiac arrest. Seventeen members of the 23-man panel said they thought that the figures showed a "suggested" risk but still voted to keep the drug on the market.

The panel did not explicitly recommend that Glaxo change its labelling of the drug, although some members of the panel suggested that label changes could be made in some circumstances.

The FDA will now collate the comments from the members of the panel and publish its decision which could include a ruling to make Glaxo change the labelling on Avandia.

The row over the drug erupted in May when an American medical journal reported a 43 pc increased risk of a heart attacks from diabetes sufferers taking the drug. The drug has also been linked, subsequently, with increased numbers of bone fractures in women taking the drug.

Glaxo has maintained that if the drug is carefully prescribed, the benefits to diabetes sufferers outweigh the risks. It also claims that during the course of its own extensive trials, it found that there was no increased incidence of heart problems compared with diabetes sufferers taking rival treatments such as Actos, a Japanese drug.

More than 21 million people in the US suffer from diabetes, which is the leading cause of new cases of blindness. Diabetes sufferers either do not produce enough insulin to break down sugar, or their insulin fails to work properly. Unlike a number of older, generic drugs to treat diabetes which try to kick start the pancreas to produce more insulin, Avandia makes the body more sensitive to the insulin it already produces.

Worldwide sales in the three months to June dropped to £349 million from £477 million a year ago, the company reported last week.

Source:business.timesonline.co.uk