DRUGS giant GlaxoSmithKline (GSK) has been dealt a heavy blow by European regulators, who are forcing it to remove diabetes drug Avandia from the market on concerns it is linked to increased heart attacks and strokes.
Yesterday’s decision by the European Medicines Agency (EMA) to suspend all marketing of Avandia came after a lengthy review and consultation period.
The EMA’s decision coincided with a ruling by the US Food and Drug Administration (FDA) that GSK could continue to market the diabetes drug – also known as rosiglitazone – but with severe restrictions.
GSK’s chief medical officer Ellen Strahlman said: “We are making every effort to ensure that physicians in Europe and the US have all the information they need to help understand these regulatory decisions.”
Analysts have said that yesterday’s ruling is likely to have a negative impact on GSK’s future sales streams.
Global sales for Avandia reached £771m last year, while the drug generated £321m in sales during the first half of 2010.
Meanwhile, European sales of the drug during the first half of the year reached £72m, and in the US Avandia made £164m.