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 panel voted the company released solid two-year data with a somewhat improved side effect profile and continued weight-loss well ahead of FDA guidelines for an approval.
As Bloomberg notes, Qnexa works better than lorcaserin and Eric Colman, deputy director of the FDA's Division of Metabolism and Endocrinology Products, said he was surprised by the advisory panel's vote.
Meanwhile, Orexigen's Contrave will face scrutiny from an FDA expert panel in early December. But there are safety concerns, including the possibility of cardio and psych side effects. Orexigen bet that combining two well known drugs--the antidepressant bupropion and naltrexone--gives it a mountain of safety data to rely on-but analysts aren't so sure. The FDA is scheduled to decide on the drug by Jan. 31, Bloomberg notes.
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