Experts are re-examining a clinical trial of the GlaxoSmithKline diabetes drug Avandia, restricted in the US and banned in Europe amid concerns it raises heart attack risk, regulators said Wednesday.
The purpose is to vote on whether the restrictions should be amended.
The Food and Drug Administration said a 28-member panel is to rule on a new analysis of the results of a GSK trial called RECORD, which confirmed the company’s initial finding that Avandia does not raise cardiac risk any more than other diabetes drugs on the market.
GSK recently paid researchers at Duke University in North Carolina to carry out this new analysis of the data.
FDA experts said this week on the agency’s web site that “overall it appears that Duke’s readjudication procedures and execution were rigorous.” A readjudication is an independent review.
“Overall, the readjudication supports the previous observation that, in this trial, rosiglitazone was not associated with increased all-cause mortality or increased cardiovascular mortality,” they said, referring to the active ingredient in Avandia.
The experts thus endorsed the re-evaluation done at Duke and, in effect, the conclusion expressed by GSK.
In 2010, the FDA slapped tight restrictions on use of Avandia, following the recommendations of independent experts who had concluded the drug significantly raised the risk of heart attacks.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, wrote on her blog that the meeting of experts Wednesday and Thursday is justified by public interest in Avandia and “the continued uncertainty of the risk surrounding this drug.”
“FDA is holding this meeting to have a transparent, public discussion with experts across multiple scientific disciplines on the results of the readjudication of the study,” Woodcock wrote.
The experts are to vote Thursday on whether the restrictions imposed on Avandia should be modified or not.