The majority of members on a US Food and Drug Administration advisory panel have recommended modifying the restrictions placed on GlaxoSmithKline’s controversial diabetes drug Avandia.
In the latest chapter of the long-running saga surrounding Avandia (rosiglitazone), an FDA joint advisory committee voted to continue to make the drug available to appropriate patients with the majority of the 26 members voting to either modify (13 votes) or remove (7) the strict risk evaluation and mitigation strategy (REMS) programme currently in place on the drug. Five panellists voted to continue with the REMS, while one called for a complete withdrawal from the US market.
The FDA will now decide what action to take next, though the joint committee’s recommendation is not binding, but the vote is a boost for GSK which has defended Avandia’s safety for the best part of six years. The problems started in 2007 after questions about possible links to cardiovascular problems and after much debate, which also saw GSK accused in some quarters of trying to bury negative data from the RECORD study, the FDA strictly limited access in 2010 while Europe’s regulator banned the drug outright.
RECORD compared heart attack rates in patients taking Avandia versus metformin and sulphonylurea, and in 2009, GSK said it showed no signal for heart attacks. Those findings were questioned and the FDA told GSK to enlist the services of Duke University to look at the data again.
The latter’s re-analysis suggests that Avandia does not increase the risk of heart attack more than the other diabetes drugs in the trial and the FDA convened a panel meeting. James Shannon, GSK’s chief medical officer, said “we appreciate the committee’s thorough examination of the RECORD results and will continue to work with the FDA as it considers the recommendation of the committee”.
He added that “we continue to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labelling”.
How much difference relaxing the REMS will make to Avandia sales is debatable given that the restrictions have been such that just 3,000 patients in the USA are taking what was not so long ago the most prescribed diabetes drug in the world.
