GSK wins crucial FDA vote on diabetes drug AvandiaGlaxoSmithKline's diabetes drug, Avandia, should be allowed to stay on the market but with additional warnings, advisers to the US's medicines watchdog voted yesterday.
Having spent two days hearing conflicting evidence over whether or not Avandia can pose a risk to the heart, 20 members of a 33-strong advisory committee to the Food and Drug Administration (FDA) voted to keep Avandia on the market while 12 voted to pull it and one member abstained.
However, 17 members of the panel advised that the drug should be sold with new restrictions or warnings, while three panel members said no changes were needed to the drug's prescribing information. Related Articles
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The FDA is not obliged to follow the recommendations of advisory panels, but often does.
Earlier in the day, the panel had voted that there was an increased concern about heart attacks with Avandia versus other diabetes drugs, but they voted against finding a greater risk of death with Avandia.
Controversy has dogged Avandia since 2007 when a study first claimed it could be linked to cardiac risks. But, GSK has vigorously defended the drug, saying that since then, six clinical trials have shown it to be safe.
Responding to the vote, GSK's chief medical officer, Dr Ellen Strahlman, said: "We would like to acknowledge the efforts made by the FDA to apply scientific rigour to the debate and understanding of the benefit-risk profile of Avandia,"
She added: "Following [the] recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease."
Mike Ward, an analyst at Ambrian, said last night: "I think [the vote] is stronger in favour than many people would have thought."