FDA approves Belviq (Eisai/Arena Pharma) for Obesity

The FDA has approved Belviq (lorcaserin HCl), from Eisai and Arena Pharmaceuticals, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kg/m2 or greater (Obese), or 27 kg/m2 or greater in the presence of at least one weight related comorbid condition. However the safety and efficacy of coadministration of Belviq with other products intended for weight loss and the effect of the drug on cardiovascular morbidity and mortality have not been established. The approval is based on three double-blind, randomized, placebo-controlled trials which demonstrated that Belviq along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and managing the weight loss for up to two years. The FDA has recommended that Belviq be classified by the US Drug Enforcement Administration as a scheduled drug. Post-marketing studies to assess the safety and efficacy of Belviq in obese pediatric patients, and to evaluate the effect of long-term treatment on the incidence of cardiovascular events in overweight and obese subjects will now be carried out.