FDA schedules Avandia advisory panel for July 13-14

The FDA has definitely scheduled the much-anticipated Avandia (rosiglitazone) advisory panel for July 13-14 in Gaithersburg, MD. The notification appears in the Federal Register. [Update: click here for the meeting announcement on the FDA website.] As previously speculated in the In Vivo blog, the FDA will also present a meta-analysis of trials of pioglitazone before the joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. It is also widely anticipated that Avandia nemesis Steve Nissen will make a presentation to the panel.

Here is the agenda as described in the Federal Register:

Agenda: On both days, the committees will focus primarily on the cardiovascular safety of AVANDIA (rosiglitazone maleate) Tablets, GlaxoSmithKline, a drug approved for blood glucose control in adults with type 2 diabetes mellitus. Data specific to rosiglitazone to be presented will include results from the Rosiglitazone Evaluated for Cardiac Outcome and Regulation of Glycemia in Diabetes (RECORD) Trial, observational data, health claims data, and a meta- analysis of controlled clinical trials. In addition, the FDA will present its meta-analysis of several trials of ACTOS (pioglitazone hydrochloride) Tablets, Takeda Pharmaceuticals North America, Inc., another thiazolidinedione for the same indication, in response to public documents comparing the safety of rosiglitazone to pioglitazone based on different meta-analyses performed on each of these two drugs.

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  1. […] patients is raising new questions about rosiglitazone (Avandia), which will be the subject of an extraordinary 2-day FDA advisory panel meeting in July. The study found that among elderly people taking a thiazolidinedione (TZD), the risk of stroke, […]

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