After FDA's ARNA decision, what's next for obesity drugs?
The FDA's decision to reject Arena Pharmaceuticals' application for lorcaserin raises the stakes for two other companies looking for approval for their weight-loss drugs.
The FDA's decision to reject Arena Pharmaceuticals' application for lorcaserin raises the stakes for two other companies looking for approval for their weight-loss drugs.
As Xconomy's Luke Timmerman writes, any company bold enough to develop obesity drugs in the past 10 years "has been signing up for a perilous journey." He points to the fen-phen debacle and Abbott's recent voluntary withdrawal of Meridia as examples.
Could Vivus and Orexigen be the next to falter on this perilous journey? We should find out about the fate of Vivus' Qnexa this week--the drug's PDUFA date is Oct. 28. However analysts, including Brian Orelli of The Motley Fool and Minyanville, are predicting that it may not be approved (at least at this time). During the summer, an FDA expert panel has recommended against approval of Qnexa. The vote was 6 in favor and 10 against, with many of the no voters citing the need for more safety data. Vivus, however, hasn't rolled over. Soon after the pane
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