An FDA advisory panel has voted to allow ongoing sales of the diabetes drug Avandia despite the fact that Glaxo’s former blockbuster poses a “significant safety” concern by increasing the risk of cardiovascular events.
The FDA is not required to follow the recommendations of its panels, although it usually does.
Nearly one-third of the 33-member panel voted to ban Avandia. Most panelists who voted to keep the drug on the market called for increased restrictions on its use, and said it should be used only as a second- or third-line drug for the treatment of diabetes.
For example, David Oakes, a statistics professor at the University of Rochester, told the Wall Street Journal that his vote for continued sales of Avandia should not be construed a “vote of confidence,” but rather that he was concerned about the quality of studies which link Avandia to heart attack risk.
Janet Woodcock, who heads-up the FDA’s drug division, said her agency will decide on the matter within the next few weeks.
Avandia sales have plummeted since a 2007 article in the New England Journal of Medicine reported a 43% bump in heart attack risk with the drug. Q1, 2010 world-wide sales of Avandia were reported to be $245 million, off 10% year-over-year.
The FDA panel also concluded that Avandia posed a greater heart attack risk than Actos, a rival drug made by Takeda. Both drugs were approved in 1999 for blood-glucose control in patients with Type 2 diabetes.
In the wake of the panel’s announcement, Glaxo’s Chief Medical Officer Ellen Strahlman defended the safety record of Avandia. She said the drug would remain on the market pending the FDA’s decision.