Weight-loss drug obtains FDA approval

After 13 suspenseful years, the US Food and Drug Administration (FDA) has approved a pill that could help to fight the US obesity epidemic.

According to the FDA, Belviq (lorcaserin) can help people to lose about 3–4% of their body weight when combined with a healthy diet and exercise. The drug has been approved for use by obese people with a body mass index (BMI) greater than 30, and for a subset of overweight people (with a BMI of more than 27) who have health conditions such as high blood pressure, elevated cholesterol and type 2 diabetes.

The FDA had already rejected Arena’s first application for approval of Belviq in September 2010 because the compound seemed to produce tumours in rats and because the company could not statistically rule out an increase in the risk of heart-valve problems. Similar to fenfluramine, Belviq suppresses food cravings by mimicking the effects of serotonin in the brain, making people eat less and feel full. However, Belviq seems to activate only the serotonin 2C receptor in the brain, not the serotonin 2B receptor that is present in heart muscle.

The FDA’s turnaround this week came after Arena performed echocardiograms in nearly 8,000 people to measure heart-valve function, which revealed that there was no increase in heart-valve abnormalities among those taking the drug. The firm has agreed to run six post-marketing studies, including a long-term cardiovascular trial, and patients with congestive heart failure are advised not to take the drug.

Source: Nature (doi:10.1038/nature.2012.10923) http://www.nature.com/news/weight-loss-drug-wins-us-approval-1.10923