FDA to discuss CV data for GSK's Avandia

FDA's Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5-6 to discuss the results of an independent re-adjudication of the RECORD cardiovascular outcomes trial for Avandia rosiglitazone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). In 2010, FDA restricted the use of Avandia and EMA simultaneously suspended the diabetes drug based on safety concerns from RECORD. FDA, which had noted potential bias in the trial's conduct, ordered GSK to commission an independent re-adjudication of the data (see BioCentury, Sept. 23, 2010). ...