After two days of deliberation, we saw a mixed vote on Avandia. Twelve members voted to take off the market, while 17 recommended changing the label to various degrees. Three voted that the drug should still be sold with its present warnings unchanged.
So what does this all mean? Les Funtleyder of Miller Tabak & Co says the vote is a "general positive" for GlaxoSmithKline, adding "the fact that everyone is having so much trouble with the data means there is no one obvious answer," as quoted by ABCNews. And Linda Bannister of Edward Jones says, "If they have to change the label somewhat, we're not as concerned about that. This product's revenue has already fallen significantly because of concerns about safety. Unless the drug is pulled we're not concerned we're going to see this drug be cut in half again."
Robert Langreth at Forbes says the mixed vote makes "Avandia is as good as dead as a commercial product." While Dr. Alan Kadish, president and CEO of Touro College in New York, agrees that Avandia will take a hit: "Very clearly, even if Avandia is not removed from the market, physicians will now be much more reluctant to prescribe it, and patients to take it," he says, as quoted by ABC.
"Avandia's decline further opens the door for the antidiabetics that have already filled the gap created after the first Avandia safety scare in 2007--class leader Actos as well as Merck's blockbuster DPP-4 drug Januvia (sitagliptin)," Datamonitor's Christine Henry says in a statement. "With Avandia hit by safety fears and Actos approaching patent expiry in 2011, there is also the possibility for newer drug classes to seize market share, maintaining the attractiveness of type 2 diabetes as a commercial and clinical target."
Avandia critic Dr. Steven Nissen says the committee's vote was the best he could hope for, adding that the drug is effectively gone, the New York Times reports. And as CNNMoney notes, the worst-case scenario for the company is that Avandia is pulled because of safety issues. This could open the company up for more litigation down the road, according to Damien Conover, an analyst at Morningstar, as quoted by CNN.
For its part, GSK says it will continue to work with the FDA "in the best interest of diabetes patients who face this chronic and serious disease," and advises patients to speak with their doctors.
The company's shares climbed 2.2 percent in pre-market trading after the decision.