UPDATE: FDA Panel Recommends Keeping Glaxo's Avandia On US Market

14th Jul 2010 22:54

(Updates with Glaxo comments and information on India trial suspension starting in 10th paragraph.) By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON (Dow Jones)--A U.S. Food and Drug Administration panel voted Wednesday to recommend that GlaxoSmithKline PLC's (GSK) diabetes drug, Avandia, remain on the market despite concerns the product could raise the risk of heart attacks. Of the 33 members, 20 voted to keep Avandia on the market, although most said the product should be subject to additional restrictions or used only if other diabetes drugs don't work. Twelve people voted to remove the product from the market, and one person abstained. The panel had five choices on the Avandia marketing question. Three panel members voted to keep Avandia on the market as is, and seven voted to strengthen warnings. Ten people voted to allow the product to remain on the market with additional warnings and some sort of restricted distribution plan or additional doctor and patient education. The panel recommendations will be taken into consideration by the FDA, which will make the final decision about whether Avandia stays on the market. In 2007 a similar FDA panel overwhelmingly voted to keep Avandia on the market and the FDA agreed with that advice. The warning label for Avandia was strengthened to say the product could increase the risk of heart attacks. Janet Woodcock, the head of the FDA's drug division said the FDA would take the panel recommendations into consideration as the agency "evaluates the regulatory options available to us." Earlier Wednesday, the panel said the data on Avandia were enough to raise significant safety concerns about the product. The panel voted 21 to 3 in favor of a question that asked whether clinical data showed that Avandia increased "ischemic CV events" relative to Actos, a similar drug made by Takeda Pharmaceutical Co (TKPYY, 4502.TO). Nine panel members said they weren't sure or couldn't make a finding one way or the other. While several panel members said they had concerns about Avandia's safety, some said existing clinical data isn't strong enough to support removing Avandia from the market. Panel member David Oakes, a biostatistics professor at the University of Rochester, said his vote to keep Avandia on the market wasn't a "vote of confidence" in the product, but reflected concerns about the quality of the various Avandia studies discussed at the meeting. The panel voted 19 to 11 in favor of allowing a Glaxo-funded study known as Tide to continue in order to compare the cardiovascular risks of Avandia and Actos if the FDA allows Avandia to stay on the market. Tide's lead researcher, Hertzel Gerstein of McMaster University, told the panel that study investigators have had trouble recruiting patients, meaning results are unlikely before 2015. Separately, Glaxo said it had suspended testing of Avandia at Indian sites participating in Tide, after the Indian government requested a hold due to recent studies raising safety concerns. In regard to the FDA panel recommendations, Ellen Strahlman, Glaxo's chief medical officer, said the company would "continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease." Avandia's safety has been in question since a 2007 article in the New England Journal of Medicine by Cleveland Clinic cardiologist Steven Nissen showed it raised the risk of heart attacks by more than 40%. Nissen's study was an analysis of 42 existing studies, most of which lasted a year or less. GlaxoSmithKline has argued that long-term studies don't show such a risk. Heart failure from excess fluid retention has been a long-recognized problem with Avandia and Actos, and both products already carry the FDA's toughest boxed warning discussing that risk. The issue with Avandia is whether it raises the risk of heart attacks and other cardiovascular problems more than other diabetes treatments. Glaxo's American depositary shares ended up about 1.8% at $36.35 and were up another 1.8% to $36.99 in after-hours trading. Avandia was once a multibillion-dollar-a-year medicine and one of Glaxo's top-selling drugs. Since the drug has come under attack, sales have slumped. In the first quarter of this year, worldwide sales of Avandia were about $245 million, down 10% from a year earlier. Both Avandia and Actos were approved in 1999 as a treatment for Type 2 diabetes, the most common form of the disease, and are both designed to lower blood-glucose levels. Diabetes affects about 24 million Americans and is characterized by high blood glucose levels caused by the body's inability to either make or properly use insulin. -By Jennifer Corbett-Dooren, Dow Jones Newswires; 202-862-9294; [email protected] (Peter Loftus contributed to this article.) (END) Dow Jones Newswires July 14, 2010 17:54 ET (21:54 GMT)