The Food and Drug Administration released information Tuesday suggesting it's unimpressed by a weight-loss medication under development by Arena Pharmaceuticals Inc. and casting doubt on the drug's eventual approval.
An FDA advisory committee is scheduled to meet Thursday and vote on whether to recommend approval of the drug, lorcaserin.
But in documents released Tuesday in advance of the meeting, the FDA noted that studies on lorcaserin showed the average weight loss while taking the drug was not significantly different than the average weight loss among people taking a placebo. However, in a study published earlier this year, the number of people taking lorcaserin who achieved at least 5% body weight loss was more than twice that achieved by the placebo group, 47.5% compared with 20.3%.
