FDA considering lifting Avandia REMS

Three senior FDA officials said in a memo that the readjudicated results from the RECORD trial are "reassuring" of the cardiovascular safety of Avandia rosiglitazone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). The agency plans to ask whether REMS requirements that severely restrict the use of Avandia should be maintained, modified or lifted, or whether the diabetes drug should be withdrawn, according to (see BioCentury, July 19, 2010).

In the briefing materials for this week's meeting, Karen Murry Mahoney, a lead medical officer in the Division of Metabolism and Endocrinology Products, said Marciniak presented his 2010 analysis as a blinded review but that the case reviews he used were not blinded. "This is not an acceptable review procedure if one wants to put forth one's review work as blinded," she wrote. ...