FDA easing Avandia restrictions

FDA Avandia rosiglitazone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in 2010. The agency made the decision based on the re-adjudication of the RECORD cardiovascular outcomes trial, which showed no evidence Avandia increased the risk of all-cause mortality or a composite of cardiovascular death, myocardial infarction (MI) or stroke. According to FDA, the re-adjudication provides "adequate assurance" that the cardiovascular signal is no longer so "worrisome" as to require the restrictions (see BioCentury Extra, May 28).

In June, a joint meeting of FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to loosen Avandia's REMS -- which includes a patient and prescriber certification program, as well as a restricted distribution system -- based on the RECORD readjudication. Healthcare professionals and patients will now no longer be required to enroll in a REMS program to prescribe, dispense or receive rosiglitazone-containing medicines and the drug will once again be available from retail pharmacies. The updated REMS will still require a prescriber education program (see BioCentury, Sept. 9). ...