Panel backs lighter Avandia restrictions, but drug's rehabilitation unlikely
This article was originally published in Scrip
Executive Summary
While a US FDA advisory committee on 6 June was not ready to completely vindicate GlaxoSmithKline's RECORD study of the firm's once-blockbuster, now restricted, Type II diabetes drug Avandia (rosiglitazone), a majority of the panelists said they were now more comfortable with the results – although most still considering the trial flawed – and voted to loosen the restrictive program on the medicine, whose scripts have fallen by 99% since the product's 2006 glory days.