FDA Puts Ongoing Glaxosmithkline Avandia Study On Partial Hold

21st Jul 2010 17:52

By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON (Dow Jones)--The Food and Drug Administration said Wednesday it's placed a partial hold on an ongoing clinical study involving GlaxoSmithKline PLC's (GSK) diabetes drug Avandia. The study, known as TIDE, is designed to compare the cardiovascular risks of Avandia to Actos, a similar drug made by Takeda Pharmaceutical Co (TKPYY, 4502.TO). The FDA said the partial hold will continue pending the agency's overall review of Avandia's safety. Last week an FDA panel voted to leave the product on the market, but many called for additional restrictions. The FDA said no new patients may be enrolled into the trial until further notice, but that people already in the study will be allowed to continue to participate. The FDA said it has instructed GSK to update study investigators, institutional review boards and ethics committees involved in the TIDE trial about new safety information presented at the FDA panel meeting. The FDA said such information should be used to update the informed consent forms for current trial participants. Some people including FDA's drug-safety officer David Graham have said the TIDE study is unethical because it subjects patients to a drug with known safety risks. In a statement, GlaxoSmithKline said it would work with the TIDE Steering Committee to send a summary of recent safety data and a summary of the FDA panel meeting to all researchers and institutional review boards. "This pause in enrollment will give clinical trial investigators and patients time to learn about the data presented to the FDA Advisory Committee and the Committee's recommendations," said Dr. Ellen Strahlman, Glaxo's chief medical officer. "We are committed to working with the FDA in the best interest of diabetic patients." -By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [email protected] (END) Dow Jones Newswires July 21, 2010 12:52 ET (16:52 GMT)