April 13th, 2013
FDA Schedules Another 2-Day Avandia Advisory Panel
Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2-day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on April 15, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to “discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial.”
The RECORD trial was one of the major topics of contention at the 2010 rosiglitazone advisory panel. Designed ostensibly to test the effect of rosiglitazone on cardiovascular outcomes, RECORD was the subject of intense and often brutal criticism from FDA reviewers and Steve Nissen. One result of the 2010 panel was that GSK commissioned Duke University to perform an independent review and analysis of RECORD. This review will apparently be the subject of the June meeting.