FDA panel backs looser Avandia REMS

A joint meeting of FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted on Thursday to loosen the REMS for diabetes drug Avandia rosiglitazone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). Among the 26 members on the panel, 13 voted to modify the REMS, seven voted to remove the REMS, five voted to maintain the REMS and one voted to withdraw Avandia from the market. Of the 13 who voted to modify the REMS, 12 wanted to ease restrictions. The vote came after a two-day meeting to discuss the readjudication of the RECORD cardiovascular outcomes trial for Avandia.

All of the panel members said they couldn't completely rule out a risk due to the open-label nature of RECORD, but felt that the risk was small based on the readjudicated data, which showed no evidence that Avandia increased the risk of all-cause mortality or a composite of cardiovascular death, myocardial infarction (MI) or stroke. ...