Avandia rosiglitazone regulatory update

FDA issued a drug safety communication in which it announced a plan to hold a joint meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees in July to review the safety of GlaxoSmithKline's diabetes drug Avandia rosiglitazone. Responding to a Senate Finance Committee report released earlier in the week related to Avandia, Center for Drug Evaluation and Research (CDER) Director Janet Woodcock told physicians that nothing the agency has learned since 2007, when it placed a boxed warning on the label about possible increased risk of myocardial ischemia, has changed its assessment of the cardiovascular risk posed by Avandia.

The Senate report reviewed allegations that GSK suppressed negative safety data. It also revealed that FDA drug safety staff had tried to block an ongoing head-to-head comparison of Avandia with Actos pioglitazone from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502, Osaka, Japan) because they said it is unethical. GSK issued a white paper rebutting the Senate report, which it claims "mischaracterizes and distorts" the company's safety monitoring efforts for Avandia. ...