FDA posts Avandia briefing documents ahead of next week’s advisory panel meeting

The FDA has posted the briefing documents for next week’s rosiglitazone (Avandia) advisory panel meeting. CardioBrief will be updating this page periodically with information gleaned from the documents. (See bottom of page for links to individual documents.)

Update 2: After a delay the FDA has posted the  meeting roster for the 2 day meeting.  We note the presence as voting members of Curt Furberg and Sanjay Kaul, who are generally considered skeptics. Furberg in particular is likely to favor withdrawal of Avandia. Kaul may favor continuation of the drug but would likely favor severe restrictions. By contrast, Arthur Moss and Marvin Konstam are generally perceived as more friendly to industry. Konstam in particular was a prominent defender of Vioxx.

Update 1: A key piece of evidence for the panel may be the cardiovascular safety meta-analyses performed by the FDA’s Bradley McEvoy. Here is the summary slide, suggesting a greater overall CV risk for rosiglitazone but not for pioglitazone. (Click to enlarge)

Briefing Documents on the FDA Website:

July 13-14, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee

• Meeting Announcement
• Draft Agenda (PDF – 81KB)
• Draft Questions (PDF – 233KB)
• Pre-Meeting Posting of Slides
• Briefing Information
• Draft Meeting Roster (PDF – 105KB)