GlaxoSmithKline (GSK) has said that it expects minimal sales of Avandia in future after European regulators said the diabetes pill should be withdrawn from the market and America’s medicines watchdog placed major restrictions on the drug.
The almost simultaneous rulings from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) marked an attempt to draw a line under the debate over the safety of Avandia, which has dogged GSK for three years.
In the wake of research suggesting Avandia could be linked to an increased risk to the heart, both the FDA and the EMA had been assessing the safety of the medicine.
Shares in Britain’s biggest drug maker vacillated yesterday, finally closing down 13p to £12.59, as investors fretted over the outcome of the regulators’ reviews, which came just as the market was closing.
Statements from the regulators showed they agreed on the risks associated with the drug, but reached different conclusions on action.
The EMA recommended suspending Avandia, which is expected to be endorsed by the European Commission within two weeks.
But the US body allowed it to stay, albeit with major restrictions placed on it.
Janet Woodcock of the FDA said: “Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug.”
Sales of Avandia had already plunged after health concerns emerged. Having reached £1.4bn in 2006, they slid to £771m in 2009.
After the announcements, GSK said it expected Avandia sales in the region of £100m to £150m in the second half of this year and minimal annual sales thereafter.
But Mike Ward, an analyst at Ambrian, said that could be a “bit aggressive”, pointing out that in the US, some patients would still have the option to stay on the drug in some circumstances.
GSK has vigorously defended Avandia and Dr Ellen Strahlman, GSK’s chief medical officer, said yesterday: “We are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients.”
Telegraph Uk