Arena Pharmaceuticals and Eisai announced that the FDA has approved Belviq (lorcaserin HCl) 10mg tablets 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 (BMI) of >30kg/m2 (obese), or >27kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes). This is the first FDA-approved prescription weight-loss treatment in 13 years.

This approval was based on data from three double-blind, randomized, placebo-controlled trials: BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) and BLOOMDM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus). Results demonstrated that Belviq along with diet and exercise was more effective than diet and exercise alone at helping patients lose >5% of their body weight after one year and managing the weight loss for up to two years. Belviq was recommended to be classified as a scheduled drug, and will be finalized by the US Drug Enforcement Administration (DEA).

Lorcaserin HCl is a serotonin 2C receptor agonist believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. Eisai will announce when Belviq 10mg tablets will become available.

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