Americans battling obesity and hoping for a pill to help them lose weight will have to keep waiting: A US Food and Drug Administration (FDA) panel yesterday voted against approving Arena Pharmaceuticals’ experimental weight-loss pill lorcaserin.
The FDA panel’s stamp of disapproval — which cited safety concerns about tumors seen in rats, along with higher rates of depression and memory loss among people taking the pill — comes only months after the federal regulator rejected a similar obesity drug, Vivus’s Qnexa.
With two drugs down, the only remaining contender to become the first new prescription diet drug in a decade is Orexigen’s Contrave, which will have its day before federal regulators later this year. In June, Orexigen scientists presented data at the American Diabetes Association meeting showing that Contrave helped diabetics lose weight and control their blood sugar better than a placebo.
As a further setback to the diet drug field, half the 16 members of a FDA advisory panel recommended Wednesday that the agency take Abbott Laboratories’s weight-loss drug Meridia off the market. A study out this month in the New England Journal of Medicine found the risk of a cardiac disease was 16% higher among people taking Meridia compared to placebo.
Besides Meridia, the only other prescription diet drug on the market is orlistat, which is sold under the trade name Xenical by Genentech/Roche, and over-the-counter as Alli by GlaxoSmithKline.
To read more about the mechanism of action of Qnexa and related drugs, see out earlier news story on anti-obesity medications.