FDA Panel Recommends Lorcaserin for Obesity
Joe Barber Jr, PhD
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May 15, 2012 ( UPDATED May 16, 2012 ) — In an 18-to-4 vote with 1 abstention, the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee last week recommended the approval of lorcaserin (Arena Pharmaceuticals) for the treatment of obesity. The recommended indication for the drug is as an adjunct to diet and exercise for weight management in patients with a body-mass index (BMI) of 30 kg/m2 or a BMI of 27 kg/m2 with weight-related comorbidities.
It was the second time lorcaserin has gone before the advisory committee, which in 2010 gave it a negative review over concerns it could cause cancer. The FDA rejected the drug’s application, citing that potential safety issue.
The panel was charged with answering a single question: “Do the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals?”
The FDA previously rejected a new drug application for lorcaserin in 2010, citing increased risks for cancer. New data submitted by Arena Pharmaceuticals appeared to alleviate many of those concerns, and the FDA agreed in a background report that the risk for tumors in patients is “negligible.”
However, despite voting yes, panel member Jack Yanovski, MD, PhD, from the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Rockville, Maryland, argued that Arena had not conclusively demonstrated that lorcaserin did not increase the risk for breast cancer.
The panel also expressed concern about the apparent increased risks for valvulopathy and adverse cardiovascular events associated with lorcaserin. A number of panel members suggested requiring echocardiograms before prescribing lorcaserin.
Panelists who voted against approval indicated that the drug’s uncertain risk profile outweighed the modest benefits of the drug. In clinical trials, participants taking lorcaserin lost only 3.1% more weight in 1 year than those in the placebo group, falling short of a key FDA criterion for drugs targeting obesity.
However, 38% of participants in the lorcaserin group lost at least 5% of their starting body weight compared with 16% of those in the placebo group.
In voting no, Sanjay Kaul, MD, from the University of California, Los Angeles, argued that the benefits of lorcaserin do not exceed its risks.
“Benefit–risk assessment is essentially a qualitative science grounded in quantitative data and dependent upon judgment,” Dr. Kaul said during the meeting. “Using this framework, the totality of evidence does not persuade me to conclude that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals.”
In February, the advisory panel gave the FDA a nearly unanimous recommendation in favor of approving the obesity drug Qnexa (Vivus), a combination of phentermine and controlled-release topiramate. If the agency approves that drug and also takes the panel’s advice on lorcaserin, they would become the first approved medications for treating obesity since the advent of orlistat (Xenical, Roche; Alli, GlaxoSmithKline) in 1999.