GlaxoSmithKline Suspends Avandia Trial In India

14th Jul 2010 21:59

By Peter Loftus Of DOW JONES NEWSWIRES GlaxoSmithKline PLC (GSK, GSK.LN) has suspended testing of its embattled diabetes drug Avandia at Indian sites participating in a global clinical trial, after the Indian government requested a hold due to recent studies raising safety concerns. The Drug Controller General of India wrote to Quintiles Transnational, a contract-research organization that is running the Avandia trial in India, asking that the study be placed on hold, said Glaxo spokeswoman Mary Anne Rhyne. The regulator cited analyses published in the U.S. last month that reinforced heart-related safety concerns about Avandia. All sites in India participating in the trial were informed of the hold status by letter on June 30, Rhyne said. The GlaxoSmithKline-sponsored trial, titled "Tide," began last year and was slated to enroll about 16,000 people globally and run through 2015. Its aim is to test the cardiovascular safety of Avandia versus the diabetes drug Actos from Takeda Pharmaceutical Co. (4502.TO). The Drug Controller General of India asked for a suspension of the Tide trial at Indian sites due to the recent publication of data on Avandia, Rhyne said. Glaxo will provide the government with any further data or information in advance of a final decision on the study, she added. Rhyne said she wasn't aware of this happening in other countries where the Tide study is being conducted. Wednesday afternoon, a U.S. Food and Drug Administration advisory panel voted to keep Avandia on the market, though some panel members voted for its removal. The same panel subsequently voted that the Tide study should continue if Avandia remains on the market. CBS News reported the suspension of the Indian portion of the Tide trial on its website earlier Wednesday. GlaxoSmithKline's American depositary shares ended 63 cents higher to $36.35 Wednesday. -By Peter Loftus, Dow Jones Newswires; +1-215-656-8289; [email protected] (END) Dow Jones Newswires July 14, 2010 16:59 ET (20:59 GMT)