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.Read article >>
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