The FDA may call the head-to-head study of GlaxoSmithKline's (NYSE: GSK) Avandia diabetes drug to a halt on worries about safety. And if the agency does put a stop to the TIDE trial--which pits Avandia against Takeda's Actos--it might also pull the drug off the market, the Wall Street Journal reports.
The FDA has called in the Institute of Medicine to review the ethics of head-to-head studies that include a drug with known risks, such as the evidence of Avandia's links to cardiovascular problems. Meanwhile, the agency notified Sen. Chuck Grassley, who has questioned Avandia's safety and the FDA's approach to regulating the drug, that it's reconsidering the TIDE trial "based on expert input and our own analysis," the Journal reports.
FDA Deputy Commissioner Joshua Sharfstein tells the WSJ that no decision has been made on the trial yet. He's asked the IOM to have its report ready for a July advisory panel meeting on Avandia. The fate of the trial "cannot be delinked from the agency's view of Avandia," he says, implying that if the trial is stopped, Avandia sales may be stopped, too.
For its part, GSK says it "welcomes additional scientific information that could help guide decisions around clinical trials and ultimately patient safety." For those decisions, we'll have to wait until July.