GSK welcomes Avandia recommendation

GlaxoSmithKline (GSK) has welcomed a recommendation from the US Food and Drug Administration (FDA) to maintain the ongoing availability of Avandia (rosiglitazone maleate), with the firm to provide further information to aid the final decision regarding the compound.

This recommendation follows the presentation of trial data assessing the orally-administered antidiabetic from the firm, including 116 clinical trials involving over 52,000 patients.

An advisory committee of the FDA voted that – though the data for Avandia suggests some ischemic risk – the drug should continue to be available to type two diabetes patients in the US.

The committee also did not evaluate the comparative risk of Avandia with other orally-administered antidiabetics.

Dr Ronald Krall, chief medical officer at GSK, said: “The committee recognized the debilitating nature of this disease and the importance of multiple treatment options.”

He added that it is vital that Avandia remain a treatment option for patients, with diabetes being a progressive disease that can have a “terrible” effect on those afflicted with the condition.

In May 2007, GSK claimed that a report in the New England Journal of Medicine regarding adverse cardiovascular effects arising from the use of Avandia was based on an inadequate meta-analysis of studies lacking rigour.