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More limits on GSK's Avandia

Jan 30, 2008 | Andrew Jack | FT News

GlaxoSmithKline, the UK-based pharmaceutical company headed by Jean-Pierre Garnier, has received a fresh blow to the prospects for Avandia, its diabetes drug, with European regulators imposing tighter restrictions on its use.

The European Medicines Agency (EMEA) warned that the drug, among the most important in GSK's portfolio, should only be prescribed after careful evaluation to patients suffering from ischaemic heart disease, or reduced blood supply to the heart muscle. It added that it should only be used in combination with insulin "in exceptional cases and under close supervision".

It said that treatment with Avandia appeared to be associated with an increased risk of ischaemic heart disease, while stressing that it did not seem to be linked to an increased risk of death.

The latest assessment move follows a similar ruling from the US Food & Drug Administration last November that expanded the severe "black box" warning on the medicine's use.

GSK's most recent results show that Avandia sales fell 38 per cent to £225m for the third quarter of 2007 worldwide, including a 48 per cent drop in the US to £130m. It anticipated a further drop in sales during the current year.

Gbola Amusa, a pharmaceuticals analyst at UBS, said that while the reaction in Europe was likely to be more modest than in the US, the EMEA's new warning placed a risk to about a quarter of Avandia prescriptions in the region.

Like the FDA, the EMEA's latest guidance enhanced the relative benefit of Actos, the rival medicine developed by Takeda of Japan for patients with type 2 diabetes.

The regulatory decisions were triggered by an international review of safety data on Avandia after publication of an academic article in the New England Journal of Medicine last May warning of side effects.

That sparked widespread concern by patients and doctors in the US, leading to a sharp drop in prescriptions even though regulators stressed that the benefits of the medicine still outweighed the risk and did not justify its withdrawal from the market.

GSK, which has conducted more extensive clinical trials on Avandia than exist on Actos, has pledged to undertake a head-to-head study designed to measure more precisely the relative merits of each medicine.